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FDA Goes on Approval Binge

Several new drugs win agency nod

During the past few days, the FDA has given the green light to a roster of new treatments, including an intravenous flu drug, a combination pill for hepatitis C, and a novel leukemia treatment. These approvals are summarized in the following sections.

Rapivab for Influenza

            On December 22, the FDA approved Rapivab (peramivir injection, BioCryst Pharmaceuticals), an intravenous (IV) neuraminidase inhibitor, for the treatment of acute uncomplicated influenza in patients 18 years of age and older who have been symptomatic for no more than 2 days.

            The approval was supported by positive data from more than 2,700 subjects treated with peramivir in 27 clinical trials. In January 2010, IV peramivir was launched in Japan under the trade name Rapiacta. It is estimated that more than 1 million patients have received peramivir treatment to date.

            The recommended regimen for Rapivab is a single 600-mg dose administered via IV infusion for 15 to 30 minutes in most patients 18 years of age or older with acute uncomplicated influenza.


Erwinaze for ALL

            On December 19, the FDA gave the nod to IV Erwinaze (asparaginase Erwinia chrysanthemi, Jazz Pharmaceuticals) as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to Escherichia coli-derived asparaginase.

            The agency’s decision was based on a pharmacokinetic study of IV asparaginase E. chrysanthemi following hypersensitivity to E. coli-derived asparaginase. The study recruited a total of 30 patients. Of these, 24 were evaluable for the primary endpoint, which was the proportion of patients having an asparaginase activity level of greater than 0.1 IU/mL at 48 hours after dosing.

            Since Erwinaze is derived from the bacterium E.chrysanthemi, it is immunologically distinct from E. coli-derived asparaginase and is suitable for patients with hypersensitivity to E. coli-derived treatments.


Viekira Pak for Hepatitis C

            On December 19, the FDA also approved Viekira Pak (Abbvie) for the treatment of patients with chronic hepatitis C virus (HCV) genotype-1 infection, including those with cirrhosis.

            Viekira Pak contains three new drugs — ombitasvir, paritaprevir, and dasabuvir — that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients with decompensated cirrhosis.

            Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The agency approved Olysio (simeprevir, Janssen) in November 2013, Sovaldi (sofosbuvir, Gilead) in December 2013, and Harvoni (ledipasvir/sofosbuvir, Gilead) in October 2014.


Zerbaxa for Urinary Tract and Intra-Abdominal Infections      

            Finally, on December 19 another approval went to Zerbaxa (ceftolozane/tazobactam, Cubist Pharmaceuticals), a new antibacterial drug, for the treatment of adults with complicated urinary-tract infections (including pyelonephritis) and complicated intra-abdominal infections (administered in combination with metronidazole).

            Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. It is the fourth new antibacterial drug approved by the FDA this year. The agency gave the green light to Dalvance (dalbavancin, Durata Therapeutics) in May, to Sivextro (tedizolid, Cubist Pharmaceuticals) in June, and to Orbactiv (oritavancin, The Medicines Company) in August.

            Sources: Rapivab; December 22, 2014; Erwinaze; December 19, 2014; Viekira Pak; December 19, 2014; and Zerbaxa; December 19, 2014.

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