FDA Approves First Human Thrombin Since 1954
Evithrom gives surgeons option of choosing a human thrombin to help control bleeding
THURSDAY, Aug. 30 (HealthDay News) -- Evithrom (human thrombin) -- a blood-clotting protein derived from human plasma -- was approved this week by the U.S. Food and Drug Administration. It's the first human thrombin the FDA has approved since 1954, the only such product currently licensed, and is applied to the surface of tissue during surgery to help control oozing and minor bleeding from capillaries and small veins.
The FDA's action was based on a clinical trial involving several hundred patients, which found that Evithrom was just as safe and effective as cattle-derived thrombin.
"The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding," Jesse L. Goodman, M.D., M.P.H., and director of FDA's Center for Biologics Evaluation and Research, said in a statement. "Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma."
Manufactured by Omrix Biopharmaceuticals, Ltd., of Ramat Gan, Israel, Evithrom will be distributed by Johnson & Johnson Wound Management, of Somerville, N.J. It is obtained from carefully screened and tested U.S. donors and is subjected to further testing to reduce the risk of transmitting blood-borne diseases.