Great news for von Willebrand patients: The FDA announced last week the approval of Alphanate for the treatment of VWD. 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. It is not approved for patients with VWD Type 3 who are undergoing major surgery.
Up till now in the US, only Humate-P has been approved for VWD. Of course, other products are used off-label when needed. To have a product legally approved overcomes a big hurdle in treatment, and provides consumers more choice. Alphanate is the first biologic product approved for treatment of surgical and invasive procedures in patients with vWD.
Alphante is manufactured by Grifols Biologicals, Inc., Los Angeles, Calif. (which acquired the former manufacturer Alpha Therapeutics). It’s a plasma derived product, as is Humate-P. Alphanate undergoes two separate steps for viral inactivation to reduce the risk of blood-borne viruses.
It’s nice to report some positive news! This approval has been in the works for years. For more information on which product is best for you, ask your doctor. But also call the manufacturer, and talk to your local hemophilia organization. Thanks to Dennis Penning of the Hemophilia Foundation of Illinois for circulating this to the community, and for always keeping us informed… you rock, Dennis!
And don’t forget you can order our book, the world’s first, A Guide to Living with von Willebrand Disease, through this website. Free to families, HTCs and nonprofits.