The USFDA has approved CSL Behring’s factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD) - Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]) – for the prevention of excessive bleeding during and after surgery in VWD patients.
Caused by a deficiency or abnormality of the von Willebrand factor (a protein in the blood that is necessary for normal blood clotting), Von Willebrand disease is the most common hereditary bleeding disorder in the United States.
According to Garrett E. Bergman, M.D., Senior Director Medical Affairs, U.S. Commercial Operations at CSL Behring (5950871):
"For individuals with VWD, the most common inherited bleeding disorder, even minor surgery can present serious risks and require special care.
Humate-P, which for years has been used successfully to treat spontaneous bleeding episodes in VWD patients, can now be administered to help prevent excessive bleeding in these patients during and after surgery."
This new approved indication of Humate-P® follows the results of two separate clinical studies (one in Europe, another in the United States) that demonstrated the hemostatic efficacy and safety of Humate-P® for VWD patients undergoing major, minor and oral surgical procedures.
Find more details from the full report.
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