FDA accepts Bayer’s BLA for hemophilia A candidate

Bayer AG (Xetra:BAYN) said FDA accepted for review a BLA for BAY94-9027 to treat hemophilia A in adults and children aged 12 and older. The company declined to disclose the therapy's PDUFA date.

The BLA is based on data from the Phase II/III PROTECT VIII trial, in which all dose regimens of on-demand and prophylactic treatment with IV BAY 94-9027 met the primary endpoint of reducing annualized bleeding rate from baseline to week 36. When Bayer reported the data in February 2014, the company had hoped to submit regulatory applications for the candidate, including a BLA to FDA, in 2H15 (see BioCentury Extra, Feb. 18, 2014)...