Posted by Michael Wonder on 01 Nov 2017
Bayer announces BAY94-9027 biologics license application accepted by U.S. Food & Drug Administration
30 October 2017 - The U.S. FDA has accepted Bayer's biologics license application filing for BAY94-9027, an extended half-life site-specifically PEGylated recombinant human Factor VIII compound, for the treatment of haemophilia A in adults and adolescents 12 years of age and over.
The regulatory submission is based on the results from the PROTECT VIII pivotal Phase II/III trial designed to evaluate the efficacy and safety of BAY94-9027 when used on-demand and prophylactically once every seven days, once every five days, or twice per week.
BAY94-9027 is an investigational agent and is not approved by the U.S. FDA, the EMA or other health authorities. Earlier this fall, Bayer filed a marketing authorisation application with the EMA.
