BioCryst Pharmaceuticals Inc., maker of the flu drug Rapivab, announced Monday that the European Medicines Agency will review its drug for the treatment of flu symptoms in adults. The London-based overseer of drugs sold in the European Union will issue a decision within 210 days on whether to allow the sale of Rapivab in the EU’s 28 member states and Norway and Iceland, a market of more than 500 million consumers.
Category: BioCryst Pharmaceuticals
BioCryst Announces the Acceptance of Peramivir MAA Filing by the European Medicines Agency
BioCryst Pharmaceuticals, Inc. , a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, announced today that the European Medicines Agency has accepted the filing of its peramivir Marketing Authorization Application for treatment of symptoms typical of influenza in adults 18 years and older. The acceptance of the MAA begins the review process by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland.
BioCryst Receives Health Canada Approval for RAPIVAB for the Treatment of Influenza
RESEARCH TRIANGLE PARK, N.C., Jan. 08, 2017 — BioCryst Pharmaceuticals, Inc. , a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that Health Canada has approved RAPIVAB i 1 2 , an intravenous treatment for acute, uncomplicated influenza.i 1 2 RAPIVAB is approved by the U.S. Food & Drug Administration and is also licensed for use in Japan and Taiwan as RAPIACTAi 1 2 and in Korea as PeramiFlui 1 2.i 1 2 i 1 2This RAPIVAB approval represents an important milestone for BioCryst and for our partner, Seqirus,i 1 2 said Jon P. Stonehouse, President & Chief Executive Officer .i 1 2 i 1 2We are excited that patients in Canada will soon have an I.V. option for the treatment of influenza infections.i 1 2i 1 2 RAPIVAB is being commercialized by Seqirus globally, excluding Japan, Taiwan, Korea and Israel.i 1 2 Seqirus is a … (more)