Wilate Now Available in the U.S.
Horizons in Hemophilia, June 2010
By Leigh Carpenter, RPh, Chief Pharmacist
Octapharma USA has announced that Wilate, a newly-developed factor replacement therapy for Von Willebrand Disease, is now available in the United States. The plasma-derived, von Willebrand Factor/Coagulation Factor VIII concentrate (Human) has been approved by the FDA for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe vWD as well as those with mild or moderate vWD in whom the use of desmopressin (Stimate Nasal Spray) is known or suspected to be ineffective or contraindicated. The product is a high-purity concentrate, utilizing the solvent/detergent process and terminal dry-heating purification processes. No albumin is added as a stabilizer in the manufacturing process. Wilate is derived from large pools of human plasma collected in U.S. FDA approved plasma donation centers. The manufacturing processes yield an approximate 1:1 ratio of Factor VIII and VWF:Rco (ristocetin cofactor).
Octapharma USA (headquartered in Hoboken, NJ) is a division of Octapharma AG, one of the largest plasma products manufacturers in the world, headquartered in Switzerland. Wilate is their first coagulation product approved in the United States. The package insert lists two strengths available per vial: 450IU VWF:RCo and 450IU FVIII activities in 5ml and 900IU VWF:RCo and 900IU FVIII activities in 10ml. Packages of Wilate will contain the Mix2Vial needle-less transfer device for reconstitution.
There are now three factor products available in the U.S. that can be used in the treatment of von Willebrand disease: Wilate, Humate-P and Alphanate SD. If you have questions about Wilate or any of the treatment choices for vWD, please contact your Hemophilia Treatment Center to discuss with your physician.