FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

The US Food and Drug Administration has accepted German pharma major Bayer’s (BAYN: DE) Biologics License Application (BLA) for Kovaltry (BAY 81-8973), its investigational treatment in hemophilia A.

Bayer HealthCare is seeking FDA approval of the investigational compound, a recombinant Factor VIII compound with the proposed trade name Kovaltry, for the treatment of hemophilia A in children and adults. BAY 81-8973 is not approved by the US FDA, the European Medicines Agency or other health authorities.

"Bayer is committed to continually bringing new therapies to hemophilia A patients who need them," said David Weinreich, head, global development, specialty medicine, Bayer HealthCare Pharmaceuticals. "Today's milestone represents the next step in that commitment," he added.