The U.S. Food and Drug Administration (FDA) recently approved Alphanate®, a plasma-derived factor VIII/von Willebrand factor product, to treat specific patients with von Willebrand disease (VWD) undergoing surgery or invasive procedures. It is also approved for VWD patients in whom the synthetic hormone desmopressin is either ineffective or contraindicated. However, it is not approved for type 3 severe VWD patients undergoing major surgery.

 

Alphanate® is manufactured by Grifols, a global healthcare and pharmaceutical company headquartered in Barcelona, Spain. The product is approved to prevent and control bleeding in patients with hemophilia A (factor VIII deficiency) or acquired hemophilia A (factor VIII deficiency).                                                   

 

“This approval is an important advance for patients and their surgeons, providing them access to a proven preventive therapy that can make needed surgery possible and safer,” said Jesse L. Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research.

 

SUPPLY NOTE: A Grifols representative has reported that because of increased use of Alphanate®, the company is contacting hemophilia treatment centers (HTCs) to obtain information about their utilization patterns so that the needs of specific providers and large-volume consumers can be met on an ongoing basis.

 

Read the entire FDA release.