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New Drugs/Drug News/New Medical Devices April 2012
Surfaxin to Prevent Respiratory Distress in Infants
Lucinactant (Surfaxin, Discovery Labs) has been approved for the prevention of respiratory distress syndrome (RDS) in premature infants. This is the first synthetically created drug for RDS to be licensed in the U.S. The lungs of premature infants do not make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse, leading to breathing difficulties.
Other FDA-approved surfactants are animal-based products: beractant (Survanta, Abbott), poractant alpha (Curosurf, Cornerstone/Chiesi), and calfactant (Infasurf, Ony, Inc.). Colfosceril palmitate (Exosurf, GlaxoSmithKline/Burroughs Wellcome) is no longer marketed.
The approval of lucinactant was based on a randomized controlled study involving 1,294 premature infants.
Lucinactant is expected to be available in the U.S. in late 2012. The FDA originally delayed its approval because of concerns over the drug’s shelf life and manufacturing issues.
Sources: FDA, March 6, 2012;
Ultresa and Viokace, Pancreatic Enzymes
Two new pancreatic enzyme products, Ultresa and Viokace (Aptalis Pharma), are now approved to aid in the digestion of food in patients with pancreatic insufficiency.
Ultresa, a delayed-release capsule, is used to treat children and adults with cystic fibrosis. These patients cannot digest food normally because their pancreas does not make enough pancreatic enzymes. Viokace, in combination with a proton pump inhibitor (PPI), is indicated for adults with chronic pancreatitis or for patients who have had a pancreatectomy. The safety and efficacy of Viokace in children has not been established.
Other approved pancrelipase products include Creon (Solvay), Zenpep (Eurand), and Pancreaze (Janssen).
An estimated 200,000 patients in the U.S. have pancreatic insufficiency.
Source: FDA, March 1, 2012
Lexapro for Depression And Anxiety Disorder
A generic form of escitalopram (Lexapro, Forest) has been approved to treat both depression and generalized anxiety disorder in adults. The generic tablets, made by Teva/Ivax, will be sold in strengths of 5, 10, and 20 mg.
Escitalopram and all antidepressant drugs carry a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults 18 to 24 years of age during initial treatment.
Teva will have 180 days of generic drug exclusivity.
Source: FDA, March 14, 2012
Boniva for Osteoporosis
The first generic versions of Roche’s Boniva (ibandronate sodium) once-monthly, 150-mg tablets have been approved to treat or prevent osteoporosis in postmenopausal women. Ibandronate is a bisphosphonate, a drug class that helps to increase bone mass and reduce the risk of spinal fractures.
Apotex Inc., Orchid Healthcare, and Mylan have been granted permission to sell the tablets.
A patient medication guide will accompany the product. In clinical trials, adverse reactions included back and extremity pain, indigestion (dyspepsia), diarrhea, headache, and myalgia.
On March 14, Roche lost a bid to block other manufacturers of generic drugs from releasing a generic version of Boniva after the New Jersey federal court ruled that the company would have difficulty withstanding challenges to two of the drug’s patents.
Sources: FDA, March 19, 2012;
Omontys for Anemia In Adults on Dialysis
The FDA has approved once-monthly peginesatide injection (Omontys, Affymax Inc.) to treat anemia in adult dialysis patients with chronic kidney disease (CKD). This new erythropoiesis-stimulating agent (ESA) aids in the formation of red blood cells (RBCs), thereby reducing the need for transfusions.
Peginesatide is the first new FDA-approved ESA for this condition since 2001. It should not be used in patients with CKD who are not receiving dialysis or in patients who have cancer–related anemia. It is not a substitute for RBC transfusions in patients who require immediate correction of anemia. This agent has not been shown to improve symptoms of anemia, physical functioning, or health-related quality of life in patients with CKD who are on dialysis.
The drug carries a Risk Evaluation and Mitigation Strategy (REMS).
Source: FDA, March 27, 2012
FluMist Quadrivalent Vaccine To Prevent Seasonal Influenza
FluMist quadrivalent intranasal vaccine (MedImmune) has been approved to prevent seasonal influenza in individuals 2 through 49 years of age. This is the first influenza vaccine to contain four strains of the influenza virus—two influenza A strains and two influenza B strains.
Like the company’s FluMist trivalent vaccine, which was approved in 2003, the new vaccine contains weakened forms of the virus strains and is administered as a nasal spray. Immune responses and adverse reactions with both products have been similar.
Source: FDA, February 29, 2012
Label Changes for Statin Drugs
Safety changes to the labeling for some statins have been announced. These drugs help to lower low-density lipoprotein cholesterol (LDL-C) levels. Examples of statins include atorvastatin (Lipitor, Pfizer), fluvastatin (Lescol, Novartis), and lovastatin (Mevacor, Merck).
The drug labels no longer mention the need for routine periodic monitoring of hepatic enzymes. The FDA now recommends that liver enzyme tests be performed before patients start statin therapy and thereafter, as indicated. The agency concluded that routine periodic monitoring of liver enzymes did not appear to be effective in detecting or preventing hepatic damage, which was reported only rarely.
The revised labels mention memory loss and confusion, which were generally reversed when statin therapy was discontinued. Some patients who used statins also had a small increased risk of hyperglycemia, resulting in type-2 diabetes mellitus. The labels now warn of this potential risk.
Protease inhibitors, which are used to treat HIV infection; some antibiotics; and some antifungals are contraindicated with the use of lovastatin.
Sources: FDA, February 28, 2012; The Wall Street Journal, Associated Press, February 29, 2012
Statins May Decrease Pneumonia Risk
Drugs that lower cholesterol levels might also modestly reduce the risk of pneumonia in healthy adults. In a sub-analysis of JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), the association persisted only when the researchers evaluated pneumonia that occurred before a cardiovascular event.
In the study’s primary cardiovascular-prevention patients, who were being treated because of elevated levels of C-reactive protein (CRP), the incidence rate of pneumonia was 17% lower when they received rosuvastatin (Crestor, AstraZeneca). The data provided support for ongoing studies, such as the Statins for Acutely Injured Lungs from Sepsis (SAILS) trial.
The primary results showed a 44% reduction in the rate of myocardial infarction, stroke, arterial revascularization, or death from cardiovascular causes with treatment. As a result, the FDA granted rosuvastatin an indication for the primary prevention of cardiovascular disease.
During a median follow-up period of 1.9 years, pneumonia developed in 214 rosuvastatin subjects compared with 257 placebo subjects. Rosuvastatin had little effect early in the treatment period but had a larger impact later on, particularly after 2 years. The researchers suggested that the statin might have offered a protective effect for infectious diseases because of its mild anti-inflammatory, antioxidant, immunomodulatory, anti-apoptotic, and endothelial mechanisms. It was unlikely that better health habits, better access to care, or other factors contributed to this result.
The study was limited by a lack of data on the participants’ pneumococcal and flu vaccination status. Also, some cases of pneumonia might have been missed. Moreover, JUPITER enrolled healthy people with low levels of low-density lipoprotein-cholesterol (LDL-C) and elevated CRP levels, so that these trial results might not be generalizable to other populations.
Although the absolute risk reduction was small, statins are worth studying in patients with sepsis and in other higher-risk patients, the researchers noted.
Source: Can Med Assoc J, March 2012; MedPage today, March 19, 2012
Follow-Up: No Avastin In Counterfeit Cancer Drug
Counterfeit versions of Genentech’s bevacizumab (Avastin) that were recently discovered in the U.S. contained salt, starch, and chemicals used in animal feed, plastics, and cleaners—but not the cancer-fighting ingredient used in the biologic drug. Among the compounds present were solvents and a phthalate, which is used to soften plastics. So far, the company has not received reports of serious side effects.
Source: The Wall Street Journal, February 27 and 28, 2012
Drugs Better Than Stents?
Inserting a tiny, expensive stent to treat stable coronary artery disease might not provide any more benefit than drug therapy. According to a meta-analysis conducted by researchers at Stony Brook University, as many as 75% of these operations may be unnecessary.
Stenting costs patients an average of $9,500 more over a lifetime compared with medication. Although the procedure reduces death and future heart attacks for someone who is having a heart attack, its use in patients with stable heart disease is questionable.
In eight trials, conducted between 1997 and 2005, prescribing beta blockers, angiotensin-converting enzyme (ACE) inhibitors, statins, and daily aspirin—now standard therapy for stable coronary artery disease—was just as effective as a stent for preventing chest pain, heart attacks, the need for a future intervention, and death. During a follow-up of more than 4 years, no significant differences were seen in longevity or quality of life.
Implanting a drug-coated stent carries a risk of stroke, heart attack, bleeding, kidney damage, or allergic reactions in about 1 in 1,000 people. Although some cardiologists regard stents as satisfactory for some patients, a combination of medications and lifestyle modifications is often considered the most effective therapy for preventing disease progression.
Sources: Arch Intern Med 2012; 172(4): 312–319; The New York Times, February 27, 2012;
Avonex Pen for MS Patients
Biogen Idec has announced the FDA’s approval of two separate dosing innovations for patients receiving once-weekly Avonex (interferon beta-1a) for relapsing multiple sclerosis (MS). The Avonex Pen is the first intramuscular autoinjector approved for MS.
Source: Biogen Idec, February 28, 2012
Gintuit Sheet For Gum Healing
Manufactured by Organogenesis, Gintuit is applied topically to a surgically created vascular wound bed in patients with oral mucogingival defects. This cellular sheet contains allogeneic human cells and bovine collagen for topical application in the mouth.
Mucogingival soft-tissue defects can result from anatomical deformities, trauma, or infection and generally involve a loss of attached gum tissue. The resulting soft-tissue inflammation is not resolved by oral hygiene alone. Gintuit secretes human growth factors and other proteins involved in wound repair. In two studies, Gintuit was associated with an increase of at least 2 mm of gingival tissue in approximate;y 50% of patients.
Source: FDA, March 9, 2012
Iliac Stent for PAD
Abbott’s Absolute Pro vascular self-expanding stent system has been approved for patients with atherosclerotic iliac arteries. A form of peripheral artery disease (PAD), iliac artery (aortoiliac occlusive) disease can lead to walking difficulty, chronic pain, and disability if the plaque reduces blood flow to the lower limbs. The flexible nitinol stent system conforms to arterial lesions.
Sources: The Wall Street Journal and Bloomberg News, March 7, 2012
Silicone Gel Breast Implant
The FDA has approved a silicone gel-filled breast implant, made by Sientra, for breast augmentation in women who are at least 22 years of age and for breast reconstruction in women of all ages. The implants are not lifetime devices, and long-term monitoring is essential. In previous studies of other implants, complications included capsule contracture, a need for more surgery or implant removal, asymmetry, and infection.
Source: FDA, March 9, 2012
LINX System for GERD
The LINX Reflux Management System (Torax Medical) is approved for patients with chronic gastroesophageal reflux disease (GERD). LINX is a sterile, surgically placed device for treating symptoms associated with GERD.
Titanium beads, each with a magnetic core, are connected together with titanium wires to form a ring shape. The device is implanted at the lower esophageal sphincter (LES), which prevents the backward flow of stomach contents. The force of the magnetic beads provides additional strength to keep a weak LES closed.
Patients who receive the LINX implant cannot undergo magnetic resonance imaging because the magnetic beads interfere with the machine and can cause the device to be damaged and may cause injury to patients.
Source: FDA, March 22, 2012
NEW MEDICAL DEVICES
Marvin M. Goldenberg, PhD, RPh, MS
Name: Accu-Chek Nano SmartView Blood Glucose Monitoring System
Manufacturer: Roche Diagnostics Inc., Indianapolis, Ind.
Approval Date: January 12, 2012
Purpose: Test strips are used to meassure blood glucose levels in diabetic patients.
Description: The meter is smaller than a credit card and has a bright back-lit display. Operating buttons are located on top of the meter.
Benefit: No coding is needed to calibrate the meter to the respective test strips, and there is no need to enter the coding key manually. Test reminders, pre-meal and post-meal markers, and calculations of average glucose levels are included. The meter’s ease of use is designed to help patients can check their blood glucose levels frequently and thus modify their therapy and incorporate lifestyle adjustments.
Name: Stratify JCV Antibody ELISA Testing Service
Manufacturer: Quest Diagnostics, Madison, N.J.
Approval Date: January 28, 2012
Purpose: This antibody-based blood test is used to determine whether a patient has been exposed to the John Cunningham virus (JCV) by detecting anti-JCV antibodies. The assay is validated for patients with multiple sclerosis (MS). The results are used to assess a patient’s risk of developing progressive multifocal leukoencephalopathy (PML), a disease caused by JCV. PML, a severe brain infection, mostly affects patients with MS who take natalizumab (Tysabri, Biogen Idec/Elan) for relapsing MS.
Description: The technology is licensed from Biogen Idec and is offered only through Quest’s Focus Diagnostics laboratory in the U.S. The test can help health care practitioners determine the risk of PML faced by patients with MS and Crohn’s disease. Exposure to JCV is generally harmless, but patients with weakened immune systems, such as those who use immunomodulatory therapies like natalizumab, have an increased chance of developing PML from JCV. PML usually causes death or severe disability.
Risk factors that increase the chance of PML in natalizumab-treated patients include the presence of anti-JCV antibodies; having taken natalizumab for more than 2 years; and having taken an immunosuppressant such as mitoxantrone (Novantrone Serono/OSI), azathioprine (e.g., Imuran), methotrexate, cyclophosphamide (Cytoxan, Bristol-Myers Squibb), or mycophenolate mofetil (CellCept, Roche/Genentech) before receiving natalizumab.
Benefit: Because there is no treatment, prevention, or cure for PML and no definitive way to predict who will be affected, the test can help physicians decide whether to prescribe or continue prescribing natalizumab.
Imaging Device Returns to Market
A device used in positron-emission tomography (PET) imaging, the CardioGen-82 generator (Bracco Diagnostic), is available for sale again in the U.S. after last year’s voluntary recall. A boxed warning was added to mention the risk of unintended radiation exposure risk.
The FDA approved the revised labeling for the generator, which is used to produce rubidium (Rb)-82 chloride injection. The labeling also includes enhanced testing information aimed at minimizing the risk of increased strontium radiation exposure. In July 2011, the company voluntarily recalled the generator after two patients received excessive radiation because of “strontium breakthrough.”
The high radiation exposure was probably the result of user error. New alert limits are established for strontium-82 and strontium-85 levels in the generator eluate. If the eluate reaches the alert limits, additional strontium-82 and strontium-85 eluate testing is required; previously, testing had been limited to a once-daily schedule. Personnel at clinical sites are advised to review and update the instructions for their dose calibrators to ensure that the proper isotope readings are performed in the eluate testing procedures.
Sources: FDA, February 15, 2012;