ROCKVILLE, Md. -- The FDA has approved Alphanate (antihemophilic factor/von Willebrand factor complex) for von Willebrand's disease in surgery.
ROCKVILLE, Md., Feb. 2 -- The FDA has approved Alphanate (antihemophilic factor/von Willebrand factor complex) for treatment of patients with von Willebrand's disease in surgery.
The approval extends to patients in whom desmopressin is ineffective or contraindicated. Alphanate was not approved for patients with type 3 (severe) von Willebrand's disease who are undergoing major surgery.
Alphanate was previously approved for the prevention and control of bleeding in patients with factor VIII deficiency due to hemophilia A or acquired factor VIII deficiency.
Today's approval made Alphanate the first biologic product approved for treatment of surgical and invasive procedures in patients with von Willebrand's disease, which is the most common inherited bleeding disorder. Von Willebrand's disease affects an estimated 1% of the U.S. population.
In clinical studies submitted to the FDA, Alphanate was administered to 76 patients who underwent a total of 120 major, moderate, and minor surgical procedures.
On the basis of predefined criteria for efficacy, more than 90% of patients had favorable outcomes.
There were adverse reactions for 15.8% of the patients and 5.7% of infusions. The most common adverse reactions were itching, pharyngitis, paresthesia, headache, swelling of the face, rash and chills.
Jesse L. Goodman, M.D., M.P.H. director of FDA's Center for Biologics Evaluation and Research, said the approval was an important advance that will make "needed surgery possible and safer."
Alphanate is purified from pooled human plasma from carefully screened and tested U.S. donors, and contains the clotting proteins deficient or defective in von Willebrand's disease, which are factor VIII (also know as antihemophilic factor) and von Willebrand factor. Although Alphanate undergoes two separate steps for viral inactivation to reduce the risk for transfusion-transmitted viruses, the potential risk for the transmission of blood-borne viruses, and, theoretically, variant Creutzfeldt-Jakob disease, cannot be totally eliminated.