Humate-P (Antihemophilic Factor/von Willebrand Factor Complex), a drug designed for the treatment of excessive bleeding during and after surgery, has been approved by the FDA. Patients with mild, moderate or severe vWD (von Willebrand disease), an inherited disease which affects about 1% of people, are susceptible to excessive bleeding during and after surgery.
This is the second drug to be approved for patients with vWD, who experienced excessive bleeding during or after surgery, and for whom desmopressin does not work. Three months ago the FDA approved Aphanate. Unlike Aphanate, however, Humate-P is designed specifically for people with severe vWD who are undergo surgery.
Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA, said “This is an important advance for patients with vWD, including those who are severely affected by the disorder. Humate-P provides a preventive therapy that can make needed surgery not only possible, but also safer.”
Humate-P had been approved for treating hemophilia A adults – to prevent bleeding.
The much needed clotting protein from human plasma from carefully screened US donors is purified – this is Humate-P. Measures are taken to lessen the risk of transfusion-transmitted diseases. Although chances of transmitting bloodborne diseases to the patient are tiny, they do exist.
The FDA examined reports on 35 vWD patients who underwent 28 major and 7 minor surgical procedures – they were all treated with Humate-P. Humate-P was found to be either excellent or good in 91% of the patients who avoided severe hemorrhage. 30% of patients did experience hemorrhaging, however, only 9% of those were classed as severe. 24% of patients experienced nausea and 17% experienced pain as a side-effect.
Humate-P is made by CSL Behring GmbH, Marburg, Germany.
Written by: Christian Nordqvist
Editor: Medical News Today