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BioCryst’s RAPIVAB(TM) (peramivir injection) received FDA approval for treatment of influenza in adults
On Dec. 22, 2014, BioCryst Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) had 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.
RAPIVAB’s approval was supported by data from over 2,700 subjects treated with peramivir in 27 clinical trials. In January 2010, Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the name RAPIACTA® and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea under the name PeramiFlu®.
It is estimated that more than one million patients had received peramivir treatment to date. The recommended dose of RAPIVAB, in most adult patients 18 years of age or older with acute uncomplicated influenza, is a single 600 mg dose administered via intravenous infusion for 15 to 30 minutes. RAPIVAB was developed under contract from the Biomedical Advanced Research and Development Authority (BARDA/HHS), a $234.8 million contract.
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Source: GlobeNewswire
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