BioCryst announces the acceptance of peramivir MAA filing by the European Medicines Agency

BioCryst Pharmaceuticals

30 January 2017 - BioCryst Pharmaceuticals announced today that the EMA has accepted the filing of its peramivir marketing authorisation application for treatment of symptoms typical of influenza in adults 18 years and older. 

The acceptance of the application begins the review process by the EMA under the centralised licensing procedure for all 28 member states of the European Union, Norway and Iceland. Peramivir's efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.

"This filing brings BioCryst and Seqirus one step closer to making the only single-dose, I.V. influenza therapy available to an important market, the European Union," said Jon P. Stonehouse, President & Chief Executive Officer.

Seqirus, a leader in influenza prevention through the supply of seasonal and pandemic influenza vaccines to global markets, will commercialize Alpivab.

Read BioCryst Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Submission