Posted by Michael Wonder on 18 Feb 2020
FDA accepts BioCryst’s NDA for oral, once daily berotralstat (BCX7353) to prevent HAE attacks
18 February 2020 - PDUFA date is 3 December 2020.
BioCryst Pharmaceuticals announced that the U.S. FDA has accepted and filed its new drug application (NDA) for the approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema attacks.
In the filing acceptance letter, the FDA stated that they are not currently planning to hold an advisory committee meeting to discuss the NDA.
