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FDA Approves Rapivab to Help Treat Influenza in Adults

Posted on Thu, Dec 25, 2014
FDA Approves Rapivab to Help Treat Influenza in Adults

First neuraminidase inhibitor approved as an intravenous formulation

MONDAY, Dec. 22, 2014 (HealthDay News) -- Rapivab (peramivir) has been approved by the U.S. Food and Drug Administration to treat influenza in adults.

The intravenous drug inhibits neuraminidase, an enzyme that releases viral particles from infected cells, the FDA explained Monday in a news release. Rapivab is approved for people 18 and older, with acute uncomplicated influenza, who have had flu symptoms for no more than two days. It is administered as a single intravenous dose.

Rapivab's safety and effectiveness were evaluated in a randomized clinical study of 297 people with a confirmed case of the flu. Those given the newly approved drug had symptoms ease about 21 hours sooner than people who didn't take the drug, the FDA said. Common side effects include diarrhea; rare, but serious, side effects include serious skin or hypersensitivity reactions. And the FDA stressed that Rapivab and other antiviral drugs are not substitutes for getting the annual flu vaccine.

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

Rapivab is produced by BioCryst Pharmaceuticals, based in Durham, N.C.

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Tags: FDA, flu, treatment