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FDA Approves BioCryst’s Oral Flu Drug Rapivab

By Pharmaceutical Processing | December 22, 2014

NEW YORK (AP) — BioCryst Pharmaceuticals said Monday that U.S. regulators approved its drug Rapivab, an intravenous treatment for the flu.

Rapivab is a single-dose drug, and BioCryst said it is the first new antiviral influenza treatment to get marketing approval in 15 years. The drug is intended for patients who are too sick to take oral flu drugs, and the Food and Drug Administration approved it for use in patients who have been symptomatic for two days or less and who have acute, uncomplicated influenza.

Shares of BioCryst Pharmaceuticals Inc. rose 17 cents to $11.33 in morning trading.

The company received about $235 million from the U.S. Department of Health and Human Services to help fund studies of Rapivab. BioCryst said this is its first U.S. marketing approval for a drug it discovered.

Rapivab, or peramivir, was approved in Japan and South Korea in 2010 and is marketed in Japan by Shionogi and Co. It is only available in Korea on a limited basis.

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