Bayer planning submissions for hemophilia A therapy

Bayer AG (Xetra:BAYN) said on Tuesday that it plans to submit regulatory applications for BAY94-9027 to treat hemophilia A, including a BLA to FDA, in 2H15. The update came after the company reported that all dose regimens of on-demand and prophylactic treatment with IV BAY 94-9027 met the primary endpoint in the Phase II/III PROTECT VIII trial of reducing annualized bleeding rate from baseline to week 36. The open-label trial enrolled 134 hemophilia A patients previously treated with Factor VIII. Bayer said it will present detailed data from the trial at the World Federation of Hemophilia meeting in May. ...