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Drug and Device News September 2016

NEW DRUG APPROVALS

Adlyxin for Type-2 Diabetes

The FDA has approved lixisenatide (Adlyxin, Sanofi-Aventis US), a once-daily injection to improve glycemic control, along with diet and exercise, in adults with type-2 diabetes (T2D). Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and efficacy were evaluated in 10 clinical trials that enrolled a total of 5,400 patients with T2D. The use of lixisenatide improved hemoglobin A1c levels in these studies.

Source: FDA, July 28, 2016

Sustol for Chemo-Induced Nausea and Vomiting

Granisetron extended-release injection (Sustol, Heron Therapeutics) has been approved by the FDA in combination with other antiemetics for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens in adults.

Sustol is an injectable form of granisetron that uses Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for at least five days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting.

The Sustol global phase 3 development program consisted of two large, guideline-based clinical trials that evaluated the product’s efficacy and safety in more than 2,000 cancer patients. The efficacy of Sustol in preventing nausea and vomiting was evaluated in both the acute phase (one day after chemotherapy) and the delayed phase (two to five days after chemotherapy).

Source: Heron Therapeutics, August 10, 2016

OTC Flonase Sensimist For Allergies

Flonase Sensimist Allergy Relief (fluticasone furoate, 27.5-mcg spray, Glaxo-SmithKline) has won FDA approval as an over-the-counter (OTC) treatment for symptoms associated with seasonal and perennial allergies. The product was previously available by prescription as Veramyst. GlaxoSmithKline plans a 2017 launch.

Flonase Sensimist is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis, including sneezing, runny nose, itchy nose, congestion, and itchy, watery eyes, in adults and children 2 years of age and older. The indication for itchy, watery eyes is for individuals 12 years of age and older.

Source: GlaxoSmithKline, August 3, 2016

Xiidra for Dry Eye Disease

The FDA has given the nod to Xiidra (lifitegrast ophthalmic solution, Shire US, Inc.) for the treatment of the signs and symptoms of dry eye disease. Xiidra is the first medication in a new class of drugs called lymphocyte function-associated antigen 1 (LFA-1) agonists to be approved by the FDA for this indication.

Dry eye disease does not routinely occur in children. The safety and efficacy of Xiidra in pediatric patients younger than 17 years of age have not been studied.

Source: FDA, July 12, 2016

Differin Gel for OTC Acne Use

The FDA has approved Differin gel 0.1% (adapalene, Galderma Laboratories), a once-daily topical gel for over-the-counter (OTC) treatment of individuals with acne. Differin gel 0.1% is approved for use in people 12 years of age and older.

Differin gel 0.1% is the first in a class of drugs known as retinoids to be made available OTC for the treatment of acne, and contains the first new active ingredient for acne treatment for OTC use since the 1980s. Differin gel 0.1% was originally approved in 1996 as a prescription product for the treatment of acne vulgaris in patients 12 years of age and older.

Source: FDA, July 8, 2016

Generic Approvals

Rosuvastatin Calcium

Eight more companies have received final FDA approval to market rosuvastatin calcium, the generic version of the blockbuster Crestor (AstraZeneca). IMS Health estimates that Crestor had U.S. sales of about $6.7 billion for the 12 months ending with May 2016.

The FDA approved the sale of rosuvastatin calcium 5-mg, 10-mg, 20-mg, and 40-mg tablets by Apotex, Inc.; Aurobindo Pharma Ltd.; Glenmark Pharmaceuticals Ltd.; Mylan Pharmaceuticals Inc.; Par Pharmaceuticals, Inc.; Sandoz, Inc.; Sun Pharma Global FZE; and Teva Pharmaceuticals USA, Inc. An authorized generic was already for sale by Actavis, Inc. (an Allergan subsidiary), under a 2013 court settlement with AstraZeneca, which lost a last-minute effort in federal court on July 19 to prevent more generic competition on the grounds that it held orphan-drug exclusivity.

The medication is indicated, as an adjunct to diet, to treat hypertriglyceridemia or primary dysbetalipoproteinemia, and to treat homozygous familial hypercholesterolemia as adjunctive therapy or alone.

Sources: FDA and FiercePharma, July 19, 2016; Mylan Pharmaceuticals Inc., July 20, 2016; P&T, June 2016

Nilutamide Tablets

ANI Pharmaceuticals has received FDA approval to market nilutamide tablets, the first generic equivalent of Nilandron (Covis Pharmaceuticals). Nilutamide tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (stage D2). For maximum benefit, nilutamide treatment must begin on the same day as or on the day after surgical castration.

Source: ANI Pharmaceuticals, July 18, 2016

Levothyroxine Sodium Injection

The FDA has approved the sale of levothyroxine sodium for injection 100 mcg and 500 mcg (Fera Pharmaceuticals/Oakwood Laboratories), which the agency describes as the first generic version of levothyroxine sodium for injection (Fresenius Kabi USA LLC). The medication, indicated for the treatment of myxedema coma, had sales of more than $93 million during the 12 months ending in May 2016, according to IMS Health.

Sources: Fera Pharmaceuticals, July 15, 2016, and FDA, June 29, 2016

Oseltamivir Phosphate Capsules

Natco Pharma Ltd. has announced the final approval of its abbreviated new drug application filed with the FDA for 30-mg, 45-mg, and 75-mg oseltamivir phosphate oral capsules—a generic version of Genentech’s Tamiflu.

Tamiflu is an influenza neuraminidase inhibitor indicated for the treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. It is also indicated for prophylaxis of influenza A and B in patients 1 year of age and older. Tamiflu was first approved by the FDA in 1999.

Source: Natco Pharma, August 3, 2016

NEW INDICATIONS

Keytruda for Head-and-Neck Cancer

The FDA has given the green light to pembrolizumab (Keytruda, Merck), an anti–programmed death receptor-1 (PD-1) therapy, at a fixed dose of 200 mg administered every three weeks for the treatment of patients with recurrent or metastatic head-and-neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy.

Pembrolizumab is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

Pembrolizumab is now indicated for the treatment of patients with unresectable or metastatic melanoma; with metastatic non–small-cell lung cancer whose tumors express PD-L1; or with recurrent or metastatic HNSCC with disease progression during or after platinum-containing chemotherapy.

Source: Merck, August 8, 2016

Dysport for Lower-Limb Spasticity in Children

The FDA has approved the supplemental biologics license application for Dysport (abobotulinumtoxinA, Ipsen Biopharmaceuticals) for injection for the treatment of lower-limb spasticity in pediatric patients 2 years of age and older. Dysport is the only FDA-approved botulinum toxin for the treatment of pediatric lower-limb spasticity.

Dysport is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A. It is supplied as a lyophilized powder. Dysport was previously approved in the United States for the treatment of adults with cervical dystonia or upper-limb spasticity to reduce the severity of increased muscle tone in elbow, wrist, and finger flexors.

Source: Ipsen Biopharmaceuticals, August 1, 2016

Synjardy for Type-2 Diabetes

The FDA has approved an expanded indication for Synjardy tablets (empagliflozin/metformin, Boehringer Ingelheim/Eli Lilly) to include treatment-naïve adults with type-2 diabetes (T2D). Synjardy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both empagliflozin and metformin is appropriate.

Empagliflozin, a sodium-glucose cotransporter-2 inhibitor, removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.

Source: Eli Lilly, July 19, 2016

Namzaric for Alzheimer’s

Extended-release Namzaric (Allergan/Adamas Pharmaceuticals) has secured FDA approval for a new, expanded label. The drug is a once-daily, fixed-dose combination of memantine (an N-methyl-D-aspartate receptor antagonist) and donepezil (an acetylcholinesterase inhibitor).

With the new indication, patients with moderate-to-severe Alzheimer’s disease who are stabilized on donepezil (Aricept, Eisai, Inc.) can now start combination therapy directly with Namzaric. Approximately 75% of patients diagnosed with Alzheimer’s disease are in the moderate-to-severe stage of the disease, but only about one-third of these patients are treated with combination therapy.

Source: Allergan, July 19, 2016

Prevnar 13 Pneumonia Vaccine

Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein], Pfizer) has received FDA approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is the only pneumococcal vaccine approved across the lifespan.

With the FDA’s decision, Prevnar 13 is now approved for:

  • Adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 S. pneumoniae strains in the vaccine.
  • Children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by the 13 S. pneumoniae strains in the vaccine.

Source: Pfizer, July 12, 2016

Berinert for Hereditary Angioedema

The FDA has given the nod to Berinert (C1 esterase inhibitor [human], CSL Behring), a therapy for treating hereditary angioedema (HAE) attacks, for use in pediatric patients. This expands the use of Berinert into all age groups, making it the first approved HAE treatment available for patients younger than 12 years of age.

Berinert is indicated for the treatment of acute abdominal, facial, or laryngeal attacks of HAE in adult and pediatric patients. The safety and efficacy of Berinert in preventing HAE attacks have not been established.

Source: CSL Behring, July 18, 2016

NEW FORMULATIONS

Relistor Tablets for OIC

The FDA has cleared Relistor tablets (methylnaltrexone bromide, Valeant Pharmaceuticals/Progenics Pharmaceuticals) for the treatment of opioid-induced constipation (OIC) in adults with chronic non cancer pain.

Relistor subcutaneous injection (12 mg and 8 mg) was approved in 2008 for the treatment of OIC in adults with advanced illness who are receiving palliative care, and in 2014 for the treatment of OIC in adults with chronic noncancer pain.

Source: Valeant Pharmaceuticals, July 19, 2016

New Flublok Formulation

The FDA has approved the 2016–2017 formulation of Flublok (Protein Sciences Corporation), the world’s first recombinant protein-based vaccine for the prevention of seasonal influenza disease. This year the FDA mandated that two new components be made for trivalent flu vaccines, including a new H3N2 component, which is also required for quadrivalent vaccines. Flublok was originally approved in January 2013. It is the only flu vaccine made in a 100% egg-free system using cell-culture technology.

Source: Protein Sciences, July 12, 2016

FDA REVIEW ACTIVITIES

Priority Review Status

Deflazacort for Muscular Dystrophy

New drug applications (NDAs) for the investigational treatment deflazacort (Marathon Pharmaceuticals) have been accepted for filing and granted a priority review designation by the FDA. The NDAs (one for immediate-release tablet formulations and one for an oral suspension formulation) request approval of deflazacort for the treatment of patients with Duchenne muscular dystrophy, the most common and most severe form of the disease.

Deflazacort is a glucocorticoid with anti-inflammatory and immunosuppressant properties. It is not currently approved in the United States for any indication.

Source: Marathon Pharmaceuticals, August 10, 2016

Fast-Track Designations

Volixibat for NASH

The FDA has granted a fast-track designation to volixibat (SHP626, Shire) as an investigational treatment for adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. Shire is developing SHP626 as a once-daily, orally administered inhibitor of the apical sodium-dependent bile acid transporter, a protein that is primarily responsible for recycling bile acids from the intestine to the liver. NASH, a serious, chronic liver disease, has no currently approved drug treatments.

Source: Shire, July 29, 2016

MCB3837 for C. Difficile Infection

The FDA has designated the intravenous (IV) antibacterial product candidate MCB3837 (Morphochem) as a qualified infectious disease product for the treatment of patients with Clostridium difficile infection (CDI). At the same time, the FDA granted a fast-track designation for the compound’s CDI development program.

MCB3837 is a water-soluble, injectable, small-molecule prodrug of the active substance MCB3681, which is being developed for the IV treatment of CDI. Three phase 1 clinical studies have shown that MCB3837/MCB3681 is safe and tolerable. In preclinical studies, MCB3681 demonstrated gram-positive antimicrobial activity against C. difficile pathogens, including the highly virulent BI/NAP1/027 strain, with no cross-resistance to any established class of antibacterial.

Morphochem is planning to initiate a proof-of-concept phase 2 clinical trial of MCB3837/MCB3681 in patients with severe CDI in the second half of 2016.

Source: Morphochem, July 25, 2016

Breakthrough Therapy Status

Ribociclib for Advanced Breast Cancer

The FDA has granted breakthrough therapy status to ribociclib (LEE011, Novartis), in combination with letrozole, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2–) advanced or metastatic breast cancer. Ribociclib is a selective cyclin-dependent kinase (CDK4/6) inhibitor. These proteins, when overactivated in a cell, can enable cancer cells to grow and divide too quickly.

The FDA’s breakthrough therapy designation was based primarily on positive results from the phase 3 MONA-LEESA-2 trial of ribociclib in combination with letrozole in postmenopausal women with HR+/HER2− advanced breast cancer who had received no prior therapy for their advanced disease. This randomized, double-blind, placebo-controlled, global registration study met its primary endpoint of clinically meaningful improvement in progression-free survival at a preplanned interim analysis.

Source: Novartis, August 3, 2016

Pracinostat for Leukemia

Breakthrough therapy status has been granted by the FDA for the investigational drug pracinostat (MEI Pharma) in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years of age or older or who are unfit for intensive chemotherapy. In addition, an agreement has been reached with the FDA on a proposed phase 3 study design.

Pracinostat is an oral inhibitor of a group of enzymes called histone de acetylases (HDACs). HDACs belong to a larger set of proteins collectively known as epigenetic regulators that can alter gene expression by chemically modifying DNA or its associated chromosomal proteins. Abnormal activity of these regulators is believed to play an important role in cancer and other diseases.

Source: MEI Pharma, August 1, 2016

V920 Vaccine for Ebola Virus

The FDA has granted a breakthrough therapy designation for the candidate vaccine V920 (Merck) for the prevention of Ebola Zaire virus infection. In late 2014, when the Ebola outbreak in western Africa was at its worst, Merck licensed V920 from NewLink Genetics Corporation, with the goal of accelerating its development, licensure, and availability.

Source: Merck, July 25, 2016

AVXS-101 for Pediatric Spinal Muscular Atrophy

AveXis, Inc., has received an FDA breakthrough therapy designation for AVXS-101 for the treatment of spinal muscular atrophy (SMA) type 1 in pediatric patients. SMA, which causes motor neuron loss and weakness, is the most common genetic cause of infant death.

AVXS-101 is the only clinical-stage gene therapy in development for SMA. The treatment is designed to target the monogenetic root cause of SMA and to prevent further muscle degeneration by addressing the defect in and/or loss of the primary SMN gene. AVXS-101 also targets motor neurons, providing a rapid onset of effect, and crosses the blood– brain barrier, allowing an intravenous route of administration.

Source: AveXis, July 19, 2016

LOXO-101 for Solid Tumors

The FDA has granted breakthrough therapy status to LOXO-101 (Loxo Oncology, Inc.), a selective inhibitor of tropomyosin receptor kinase (TRK), for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed after prior treatment or who have no acceptable alternative treatments.

Research suggests that NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

LOXO-101 is being evaluated in a global phase 2 multicenter trial in patients with solid tumors that harbor TRK gene fusions and in a phase 1 study in pediatric patients.

Source: Loxo Oncology, July 13, 2016

Complete Response Letter

Pegfilgrastim Biosimilar

Sandoz has received a complete response letter from the FDA regarding its biosimilar of Amgen’s Neulasta (pegfilgrastim) and is working with the agency to address remaining questions. No further details were given on the rejection, which was buried in a second-quarter financial report released in July by Sandoz parent company Novartis.

The FDA had accepted the company’s pegfilgrastim biosimilar for review in November 2015. Normally, a standard review takes 10 months.

Last year, Novartis was the first to win a biosimilar approval in the United States with Zarxio, its copy of Amgen’s filgrastim (Neupogen)—a slightly different formulation of Neulasta.

Sources: FierceBiotech and Novartis, July 19, 2016

DRUG SAFETY ISSUES

Cialis and Melanoma?

Seven men who were treated with Cialis (tadalafil) tablets for erectile dysfunction have sued Indianapolis-based Eli Lilly and Company, claiming that they later developed skin cancer that was related to the medication, according to a report in the Indianapolis Business Journal. The plaintiffs, who took Cialis for periods ranging from one year to nine years, said they were treated for various skin cancers on the fingers, chest, back, and head.

The plaintiffs filed separate but similar complaints in U.S. District Court in Indianapolis, saying that Lilly knew or should have known that the drug’s mechanism of action presented “significant risk of exacerbating melanoma.” Tadalafil is a phosphodiesterase type 5 inhibitor.

The suits cite studies in several medical journals that the plaintiffs claim link tadalafil’s mechanism of action to melanoma. Lilly responded that it had reviewed the studies and had found no evidence that tadalafil causes melanoma.

Source: IBJ, August 5, 2016

Diabetes Drugs Linked To Gallbladder Disease

Two population-based studies conducted by McGill University in Canada have found no association between incretin-based drugs for type-2 diabetes and the development of acute pancreatitis, but these medications were shown to increase the risk of bile duct and gallbladder disease.

The gallbladder study was the first population-based investigation to look at the possibility of an association with incretin-based drugs. In this case, glucagon-like peptide-1 (GLP-1) analogues were found to be associated with a 79% increased risk of disease. In other words, nearly three more patients per 1,000 exhibited symptoms compared with those not taking an incretin-based medication. Gallstones were the most common adverse effect of treatment. At their most severe, they can lead to surgical removal of the gallbladder.

Source: McGill University, August 1, 2016

FDA Updates Fluoroquinolone Warnings

The FDA has approved safety-labeling changes for fluoroquinolone antibiotics to enhance warnings about their association with disabling and potentially permanent adverse effects and to limit their use in patients with less-serious bacterial infections.

An FDA safety review found that both oral and injectable fluroquinolones are associated with disabling adverse effects involving tendons, muscles, joints, nerves, and the central nervous system. These effects can occur hours to weeks after exposure to fluoroquinolones and may be permanent. Because the risk of these serious adverse effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, the FDA has determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options. For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia, the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option, according to the agency.

Source: FDA, July 26, 2016

Oral Liquid Docusate Recalled

PharmaTech, LLC, of Davie, Florida, has voluntarily recalled all nonexpired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Labs, Livonia, Michigan. The FDA confirmed that the product had been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. In addition, the FDA received several adverse event reports of B. cepacia infections in patients. Some of these reports identified liquid docusate sodium products manufactured by companies other than PharmaTech.

The FDA joined the Centers for Disease Control and Prevention in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

Source: FDA, July 16, 2016

CLINICAL TRIALS UPDATE

Opdivo for RCC

The German Institute for Quality and Efficiency in Health Care has determined that nivolumab (Opdivo, Bristol-Myers Squibb) offers advantages over everolimus in patients with renal cell carcinoma (RCC). The agency found a “major” added benefit for nivolumab in RCC patients with a poor prognosis compared with everolimus, according to the investigators. In patients with a favorable or intermediate prognosis, the added benefit of nivolumab was judged to be “considerable.”

Nivolumab also showed advantages over everolimus for two morbidity outcomes, as well as for several outcomes in the category of adverse effects.

The German agency also investigated whether nivolumab offered advantages over temsirolimus. No added benefit was observed for nivolumab in RCC patients who had received prior treatment with temsirolimus.

Source: Institute for Quality and Efficiency in Health Care, August 10, 2016

Abemaciclib for Breast Cancer

Eli Lilly and Company has announced that, following a preplanned interim analysis of the phase 3 MONARCH 2 trial, an independent data monitoring committee recommended that the study be continued without modification because the interim efficacy criteria were not met. The study will continue into the first half of 2017.

The trial is comparing abemaciclib plus fulvestrant versus placebo plus fulvestrant in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer. Abemaciclib is an investigational, oral cell-cycle inhibitor designed to block the growth of cancer cells by specifically inhibiting cyclin-dependent kinases.

Source: Eli Lilly, August 10, 2016

Humira Biosimilar Candidate

Coherus BioSciences has reported topline results from an ongoing phase 3 study of CHS-1420, an adalimumab (Humira, AbbVie) biosimilar candidate. The study met its primary endpoint, demonstrating similarity between CHS-1420 and Humira with respect to the percentage of subjects achieving 75% improvement in the Psoriasis Area and Severity Index at week 12.

This was a confirmatory, randomized, double-blind, active-control, parallel-group, three-part study in patients with active moderate-to-severe chronic plaque psoriasis. In treatment period 2, half of the subjects randomly assigned to receive Humira will cross over to CHS-1420, modeling a chronic patient’s transition to a biosimilar.

Source: Coherus BioSciences, August 8, 2016

Halaven for Soft-Tissue Sarcoma

Positive results have been reported from a phase 3 study of the anticancer agent eribulin mesylate (Halaven, Eisai) in 452 adults with locally advanced, recurrent, or metastatic soft-tissue sarcoma (liposarcoma or leiomyosarcoma) who had experienced disease progression after standard therapies, including an anthracycline and at least one other regimen. The median duration of response was 12.5 months for eribulin compared with 4.2 months for dacarbazine. In addition, eribulin demonstrated a trend for extended overall survival in each of three disease subtypes (dedifferentiated liposarcoma, myxoid/round liposarcoma, and pleomorphic liposarcoma).

Source: Eisai, August 1, 2016

Yervoy for Melanoma

Melanoma patients who received both ipilimumab (Yervoy, Bristol-Myers Squibb) and local peripheral treatments, such as radiotherapy or electrochemotherapy, had significantly prolonged overall survival compared with those who received only ipilimumab, according to a study published in Cancer Immunology Research. The study was conducted at the University Hospital of Cologne, Germany.

Median overall survival for patients receiving ipilimumab plus local peripheral treatment was 93 weeks compared with 42 weeks for those receiving only ipilimumab. After excluding patients with brain metastases from the analysis (because these patients were not distributed equally among the two treatment groups), patients receiving ipilimumab and local peripheral treatment maintained their median overall survival benefit compared with those receiving only ipilimumab (117 weeks versus 46 weeks, respectively).The findings supported results from a U.S. study of ipilimumab administered with local radiotherapy.

Source: University of Cologne, August 4, 2016

Biosimilar Trastuzumab

Efficacy and safety results have been reported from a phase 3 study evaluating biosimilar trastuzumab (ABP 980, Amgen/Allergan) compared with trastuzumab (Herceptin, Genentech) in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The results ruled out inferiority compared with trastuzumab but could not rule out superiority based on the study’s primary efficacy endpoint of the difference in the percentage of patients with a pathologic complete response. The primary endpoint had a prespecified equivalence margin of ± 13%, and the observed upper end of the confidence interval was 13.4%.

ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that targets HER2. Trastuzumab is approved in many regions for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

Source: Amgen, July 21, 2016

Brentuximab for Hodgkin’s Lymphoma

Five-year survival data, published in Blood, suggested that the targeted therapy brentuximab vedotin (Adcetris, Seattle Genetics) may have cured some Hodgkin’s lymphoma (HL) patients whose disease had persisted despite previous therapies.

A multinational phase 2 trial examined brentuximab in patients with HL who had relapsed after stem cell transplant. The study found that 13 of 34 patients (38%) who achieved complete remission remained disease-free for more than five years and may have been cured. Of those patients, nine received only single-agent brentuximab.

This is the first study to demonstrate long-term success with brentuximab in HL patients who had exhausted all other treatment options.

Source: American Society of Hematology, July 18, 2016

Reolysin for Lung Cancer

Oncolytics Biotech, Inc., has announced preliminary findings from a randomized, phase 2 study of pelareorep (Reolysin) in patients with non–small-cell lung cancer. The study enrolled patients with both nonsquamous (adenocarcinoma) and squamous cell histology. Those with adenocarcinoma (n = 75) were treated with pelareorep in combination with pemetrexed in the test arm versus pemetrexed alone in the control arm. Those with squamous cell histology (n = 76) were treated with pelareorep in combination with docetaxel in the test arm versus docetaxel alone in the control arm. The study’s primary objective was progression-free survival (PFS).

In the adenocarcinoma group, PFS was significantly better for female patients in the test arm (n = 20) than for those in the control arm (n = 16); the median PFS was 5.4 months compared with 3.0 months, respectively (P = 0.0201). No PFS benefit was observed in male patients.

Data were not available from the patients with squamous-cell histology.

Source: Oncolytics Biotech, August 10, 2016

TTP399 for Type-2 Diabetes

Positive results have been reported from a phase 2b study of TTP399 (vTv Therapeutics), a liver-selective, small-molecule glucokinase activator under development for the treatment of patients with type-2 diabetes. The study achieved its primary endpoint of a statistically significant improvement from baseline in hemoglobin A1c (HbA1c) after six months of treatment with TTP399 (800 mg once daily) compared with placebo. The reduction in HbA1c was dose-dependent and sustained throughout the duration of the study. Further analysis of the data is ongoing.

Source: vTv Therapeutics, August 10, 2016

Olaratumab for Sarcoma

Adding a new monoclonal antibody therapy to traditional chemotherapy increased median survival by nearly a year in patients with advanced sarcoma. The finding represents the first appreciable improvement in sarcoma outcomes in decades.

In the phase 2 study, 133 patients with metastatic soft-tissue sarcoma received either doxorubicin or doxorubicin plus olaratumab. The median overall survival of patients in the doxorubicin group was 14.7 months compared with 26.5 months in the doxorubicin/olaratumab group.

Source: Columbia University Medical Center, July 20, 2016

DEVICE APPROVALS

Repatha Pushtronex for LDL-C

The FDA has approved the Repatha (evolocumab) Pushtronex system (Amgen), an on-body infuser with a prefilled cartridge. The product provides a monthly single-dose administration option for evolocumab as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein-cholesterol (LDL-C). It is also approved as an adjunct to diet and other LDL-lowering therapies in patients older than 13 years of age with homozygous familial hypercholesterolemia who require additional lowering of LDL-C.

The Pushtronex system is a hands-free device designed to provide 420 mg of evolocumab in a single dose. Evolocumab is a human monoclonal antibody that blocks proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body’s natural system for eliminating “bad” cholesterol (LDL-C) from the blood. Evolocumab is the first PCSK9 inhibitor to be available as a monthly single-dose delivery option.

Source: Amgen, July 11, 2016

Aries Flu A/B & RSV Assay

The FDA has cleared the Aries Flu A/B & RSV assay (Luminex Corporation) for the detection and differentiation of three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). The new test provides results in less than two hours.

The Aries assay is a polymerase chain reaction-based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and RSV nucleic acid from nasopharyngeal swab specimens from patients with signs and symptoms of respiratory-tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of influenza A virus, influenza B virus, and RSV infections in humans and is not intended to detect influenza C.

Source: Luminex Corporation, August 3, 2016

Lumos Software for Image Enhancement

EndoChoice Holdings, Inc., has announced the FDA clearance and U.S. launch of Lumos with Adaptive Matrix Imaging. The new imaging software is part of the company’s Generation 3 Fuse Full Spectrum Endoscopy System. The software analyzes and selectively enhances the vascularity, surface texture, and color of abnormal tissue, providing detailed information for physicians to assist in their detection of abnormalities during gastrointestinal procedures.

Source: EndoChoice Holdings, August 3, 2016

Reconstitution System For Adynovate

The FDA has approved the Baxject III reconstitution system for Adynovate (antihemophilic factor [recombinant], PEGylated, Shire). The new system reduces the number of steps in the reconstitution process for patients with hemophilia A and their caregivers. Adynovate and the diluent will be prepackaged in the Baxject III reconstitution system.

The Baxject III system reduces the number of steps in the treatment process by two, compared with the previous process with the Baxject II Hi Flow Needleless transfer device. The system will be available with a 2-mL diluent for the 250-, 500-, and 1,000-IU potencies; and a 5-mL diluent for the 2,000-IU potency.

Source: Shire, August 1, 2016

Permaseal Device For Cardiac Surgery

Micro Interventional Devices, Inc., has received FDA market clearance for its Permaseal transapical access and closure device, which allows surgeons to access and close the left ventricle without suturing the myocardium.

Source: Micro Interventional Devices, July 29, 2016

New Wavelength For PicoWay Laser

The PicoWay picosecond laser (Syneron Medical Ltd.) has received FDA clearance for a new ultra-short 785-nm wavelength, which is the third FDA-cleared wavelength for the device. The ultra-short wavelength is the first of its kind in the aesthetic market. The PicoWay picosecond laser received FDA approval for the removal of tattoos in November 2014 and for the treatment of pigmented lesions in April 2015.

Source: Syneron Medical, July 25, 2016

UltraShape Power Device For Fat Destruction

UltraShape Power (Syneron Medical Ltd.), a fat-destruction device, has been cleared by the FDA for noninvasive reduction of abdominal circumference via fat-cell destruction. The device uses focused, pulsed mechanical ultrasound energy to target and destroy fat. A clinical study with UltraShape Power’s USculpt transducer demonstrated a 32% reduction in the thickness of subcutaneous fat.

Source: Syneron Medical, July 18, 2016

Intraocular Lens for Cataracts

The FDA has approved the first intraocular lens (IOL) that provides cataract patients with an extended depth of focus, which helps improve their visual acuity at near, intermediate, and far distances. The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc.

Source: FDA, July 15, 2016

ExAblate Neuro For Essential Tremor

The FDA has approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro (InSightec) uses magnetic resonance images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.

In a clinical study, patients treated with the ExAblate Neuro device showed a nearly 50% improvement in their composite tremor and motor function scores three months after treatment compared with their baseline scores. Patients in the control group (sham procedure) showed no improvement. At 12 months post-procedure, the treatment group retained a 40% improvement in these scores compared with baseline.

Source: FDA, July 11, 2016

OTHER DEVICE NEWS

Biochip-Based Blood Test For Alzheimer’s Disease

Researchers at Randox Laboratories have reported the results from a new blood test to help identify which patients are at an elevated risk of Alzheimer’s disease (AD). The findings showed that the biochip test, which allows multiple tests to be run on one blood sample, was as accurate as existing molecular tests that analyze DNA.

The new test detects the presence of a protein in the blood produced by a specific variation of the apolipoprotein gene (ApoE4), which is associated with an increased risk of developing AD. The apolipoprotein gene is inherited from each parent, and when a patient inherits the ApoE4 variant from one parent, he or she has a three times greater risk of developing AD, whereas a patient who inherits ApoE4 from both parents is eight to 12 times more likely to develop the disease.

Source: American Association for Clinical Chemistry, August 3, 2016

INRatio Devices Leave U.S. Market

Alere, Inc., has voluntarily withdrawn the Alere INRatio and INRatio2 PT/INR anticoagulation monitoring systems from the U.S. market. The devices determine the international normalized ratio (INR) in samples of capillary whole blood.

In December 2014, the company issued an “urgent correction” notice stating that the two devices, under certain circumstances, could display an INR that is lower than that obtained through a laboratory method. For the next two years, Alere worked to develop software modifications that would address the problem, but the FDA informed the company that its studies did not adequately demonstrate the effectiveness of these enhancements. The FDA advised Alere to submit a proposed plan to voluntarily remove the INRatio devices from the market.

Sources: Alere, Inc., July 11, 2016, and FDA, July 12, 2016