Bayer: submits hemophilia treatment for FDA approval.
(CercleFinance.com) - Bayer said it has submitted a filing with the US Food and Drug Administration (FDA) for a long-acting recombinant human factor in the treatment of hemophilia A.
The regulatory submission is based on results from a clinical trial that showed protection from bleeds when used prophylactically once weekly, once every five days, and twice per week, the German firm said.
Hemophilia A affects 1 in 5,000 male live births, representing approximately 30,000 people in Europe and 14,000 in the US.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The regulatory submission is based on results from a clinical trial that showed protection from bleeds when used prophylactically once weekly, once every five days, and twice per week, the German firm said.
Hemophilia A affects 1 in 5,000 male live births, representing approximately 30,000 people in Europe and 14,000 in the US.
Copyright (c) 2017 CercleFinance.com. All rights reserved.