Posted by Michael Wonder on 03 Sep 2017
Bayer submits biologics license application in the U.S. for BAY94-9027 – a long-acting factor VIII for the treatment of haemophilia A
31 August 2017 - Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals.
Bayer AG today announced the submission of a biologics license application with the U.S. FDA for its long-acting site-specifically PEGylated recombinant human Factor VIII (BAY94-9027) for the treatment of haemophilia A. The regulatory submission is essentially based on the results from the PROTECT VIII trial. In that trial, BAY94-9027 showed protection from bleeds with dosing intervals when used prophylactically once every seven days, once every five days, and twice per week.
In the PROTECT VIII study, BAY94-9027 provided good protection from bleeds when used prophylactically once every seven days, once every five days, and twice per week. BAY94-9027 was also effective for control of bleeding during surgical procedures, and treatment of all bleeds, with the vast majority of events being resolved with one or two infusions.
