BRIEF—BLA for Bayer's BAY94-9027 accepted

The US Food and Drug Administration has accepted Bayer's Biologics License Application (BLA) filing for BAY94-9027 (damoctocog alfa pegol), an extended half-life site-specifically PEGylated recombinant human Factor VIII compound, for the treatment of hemophilia 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 US FDA, the European Medicines Agency (with which it was filed earlier this fall) or other health authorities.

BAY94-9027 is engineered to potentially prolong FVIII activity in the blood while preserving coagulation activity using site-specific PEGylation technology, where a PEG (Polyethylene glycol) molecule is consistently attached to the factor VIII protein at a specific site.

An extended half-life recombinant factor VIII therapy may result in reduced frequency of infusions for people living with hemophilia A, said Bayer.