The U.S. Food and Drug Administration (FDA) announced the approval of Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate. The product is approved for patients undergoing surgery or invasive procedures with von Willebrand disease (vWD) in whom the hormone desmopressin is either ineffective or contraindicated & is considered the first biologic product approved for this indication.
Alphanate is already approved for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency.It is not approved for patients with severe vWD (Type 3) who are undergoing major surgery.
Alphanate, manufactured by Grifols Biologicals, is purified from pooled human plasma from carefully screened and tested U.S. donors, and contains the clotting proteins deficient or defective in vWD, which are Factor VIII (also know as Antihemophilic factor) and von Willebrand factor. Alphanate undergoes two separate steps for viral inactivation to reduce the risk for transfusion-transmitted viruses. However, the potential risk for the transmission of blood-borne viruses, and theoretically variant Creutzfeldt-Jakob disease CJD*, while very low, cannot be totally eliminated.
In clinical studies with Alphanate, 120 major, moderate and minor surgical procedures were performed in 76 patients. Based on predefined criteria for efficacy, more than 90 percent of patients had favorable outcomes. In these clinical studies, 15.8 percent of subjects and 5.7 percent of infusions were accompanied by adverse reactions, most commonly itching, pharyngitis, paresthesia (a sensation of numbness and tingling on the skin) and headache, swelling of the face, and rash and chills.
* Creutzfeldt-Jakob disease (CJD): is a rapidly progressive disease causing damage to the brain, and is believed to be caused by a prion.