Posted by Michael Wonder on 31 Mar 2020
EMA validates marketing authorisation application for oral, once-daily berotralstat (BCX7353) to prevent HAE attacks
30 March 2020 - BioCryst Pharmaceuticals announced that the EMA has validated its marketing authorisation application submission for approval of oral, once-daily berotralstat (BCX7353) for the prevention of hereditary angioedema attacks.
With this validation, the EMA has begun their formal review of the authorisation under the centralised procedure for all member states of the European Union, and Norway, Iceland and Liechtenstein.
