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news.BioCryst Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.
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"RAPIVAB is the first neuraminidase inhibitor that has shown to be safe and effective as a single-dose, i.v. therapy for patients with acute, uncomplicated influenza, and represents the first new antiviral treatment for influenza approved by the FDA in 15 years," said Richard Whitley, M.D., University of Alabama at Birmingham. "In a blinded, randomized placebo-controlled trial, a single dose of RAPIVAB alleviated flu symptoms, and reduced fever significantly faster than placebo."
"The approval of RAPIVAB provides a new choice to immediately deliver an effective treatment in one dose to adult patients with influenza," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "This is the first U.S. approval of a BioCryst discovered drug and represents an important milestone for our company. We thank our funding partner BARDA/HHS; the development and approval of RAPIVAB is an excellent example of a successful public/private partnership."