BioCryst flu drug moves closer to FDA filing
Durham, N.C. —
The Durham drug developer said today that it has completed its meeting with the FDA regarding its experimental flu drug. The company said that the meeting minutes confirm that BioCryst’s proposed new drug application supports submission to the FDA that the regulator can review. BioCryst is requesting another meeting with the FDA to work out what’s needed to make a complete drug application.
Peramivir is an intravenous drug that has been developed to treat patients who have influenza. The experimental drug has been developed under a under a $234.8 million contract from Biomedical Advanced Research and Development Authority, or BARDA. BioCryst said that BARDA will hold an “in-process review” meeting this quarter to discuss the future of the Peramivir development contract.
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