FDA approves Baxalta’s Adynovate

SILVER SPRING, Md. — The Food and Drug Administration on Monday announced that it had approved Baxalta’s Adynovate, a new antihemophilic factor (recombinant) for adults and adolescents aged 12 and older with Hemophilia A. The drug is a modified full-length coagulation factor meant to last longer in the blood than other drugs with the hope that it requires less frequent injections.

 

The drug is meant to be used on-demand to control bleeding episodes and as a way to reduce their frequency.

 

The approval of Adynovate provides an important therapeutic option for use in the care of patients with Hemophilia A and reduces the frequency of Factor VIII infusions needed to avoid bleeding,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.