FRIDAY, SEPTEMBER 30, 2016

BioCryst's peramivir new drug application accepted by FDA

BioCryst Pharmaceuticals, Inc., announced on Tuesday that the U.S. Food and Drug Administration accepted its new drug application for intravenous influenza treatment peramivir for review.


Peramivir is an anti-viral drug that delivers concentrations of plasma to the infection. The medication interferes with the interaction of an influenza enzyme that is critical to spreading the illness.


BioCryst said the medication has been effective against multiple strains of influenza, including H7N9 and H1N1.


"We are pleased that BioCryst's first NDA filing has been accepted by the FDA. We believe the approval of peramivir and its mode of i.v. administration would benefit many influenza patients, including those who cannot tolerate treatment by oral or inhaled administration," President and CEO Jon Stonehouse said. "BioCryst is preparing to make peramivir available in the U.S. during the 2014-15 influenza season, provided approval is granted within that timeframe."


The application was awarded a standard review, and action will take place on Dec. 23. The FDA said it is not planning on having an Advisory Committee review of the drug.


BioCryst completed a pre-NDA meeting with the FDA in June 2013. The submission included study results for more than 2,700 patients from 27 clinical trials.


Peramivir has been approved in Japan and Korea. BioCryst estimates more than 1 million patients have received the treatment.