FDA Approves Peramivir (Rapivab) for Influenza


December 22, 2014

The US Food and Drug Administration (FDA) has approved a new neuraminidase inhibitor for acute uncomplicated influenza called peramivir (Rapivab, BioCryst Pharmaceuticals), which offers clinicians another way to administer this class of antiviral medicine, the agency announced today.

Peramivir, given intravenously in a single dose, is limited to adults with influenza who have been symptomatic for no more than 2 days.

Oseltamivir (Tamiflu, Roche Group), another neuraminidase inhibitor approved to treat the influenza, is administered in the form of an enteric capsule. Zanamivir (Relenza, GlaxoSmithKline), also a neuraminidase inhibitor, is a powder that is inhaled orally. The two drugs are the only antivirals recommended by the FDA for treating seasonal influenza in the 2014 to 2015 influenza season. The agency does not recommend the use of amantadine or rimantadine, two antiviral drugs in an older class of medications known as adamantanes, because influenza A (H3N2) and the pandemic influenza A (H1N1) viruses are highly resistant to them. Furthermore, they do not work against influenza B viruses.

"Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an [intravenous] formulation," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows healthcare professionals and patients to have a choice based on an individual patient's needs."

Diarrhea is the most common adverse event associated with peramivir, according to the FDA. The drug's label also warns about the risk for serious skin and hypersensitivity reactions and neuropsychiatric events such as hallucinations and delirium.

More information about today’s announcement is available on the FDA website.


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