FDA Approves Biologic to Treat Common Bleeding Disorder

The FDA has approved Humate-P (antihemophilic Factor/von Willebrand Factor Complex), CSL Behring’s (Marburg, Germany, www.cslbehring.com) factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD). Humate-P will be used for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe VWD.

The new indication approval follows the results of two separate clinical studies-one in Europe, another in the United States. The product was originally approved in 1999 for use in adult patients to treat and prevent bleeding from hemophilia A. It was later approved to treat spontaneous and traumatic bleeding for severe VWD and for mild and moderate VWD when desmopressin use is known or suspected to be inadequate.

Humate-P works by replacing von Willebrand factor/factor VIII that is missing in patients with VWD. Humate-P is made by purifying the needed clotting protein from human plasma from carefully screened and tested US donors. The distribution of high molecular weight multimers in Humate-P corresponds closely to that found in normal human plasma.