Human Thrombin Approved by FDA

—Elizabeth Mechcatie

A human thrombin used to help control bleeding during surgery has been approved by the Food and Drug Administration.

Used topically, the product, which will be marketed as Evithrom, is the first human thrombin approved since 1954 and is the only such product currently licensed by the agency, according to an FDA statement.

The approval "offers an important additional option for surgeons and their patients to help control surgical bleeding," Dr. Jesse L. Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in the statement. The approval provides surgeons the choice between human thrombin and thrombin derived from cattle plasma.

Evithrom, which is applied to the surface of bleeding tissue and can be used with an absorbable gelatin sponge, is indicated to help stop "oozing and minor bleeding from capillaries and small veins and when control by standard surgical techniques is ineffective or impractical."

The product's safety and effectiveness were "comparable" with cattle-derived thrombin in a study of several hundred patients, according to the FDA. Evithrom is derived from human plasma from screened donors, and has undergone other steps aimed at reducing the risks of transfusion-transmitted diseases.

Evithrom, manufactured by Omrix Biopharmaceuticals Ltd., Ramat Gan, Israel, will be distributed in the United States by Johnson \& Johnson Wound Management.