The Food and Drug Administration has approved a thrombin product derived from human plasma to help control bleeding during surgery.
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 announcing the approval. The approved indication is “as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.”
The approval “offers an important additional option for surgeons and their patients to help control surgical bleeding,” and provides surgeons the choice between human thrombin and bovine-derived thrombin, Dr. Jesse L. Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in the statement.
Evithrom is applied to the surface of bleeding tissue and can be used with an absorbable gelatin sponge. The safety and efficacy of Evithrom were “comparable” with those of cattle-derived thrombin in a study of 305 patients, according to the FDA. In the study, 63 patients who received Evithrom were over age 65. No differences in product safety or efficacy were documented between elderly and younger patients, according to the product's label.
The label cites immunogenicity data from the study, which compared the presence of antibodies to bovine thrombin, bovine Factor V/Va, human thrombin, and human factor V/Va at baseline and 5 weeks after surgery in most of the patients. About 3% of those who received Evithrom developed antibodies to any of these four antigens, compared with nearly 13% of those who received bovine-derived thrombin. Nearly 8% of those in the latter group developed antibodies to bovine thrombin, and nearly 10% developed antibodies to bovine factor V/Va, while none of those treated with Evithrom had detectable antibodies to human thrombin or to human factor V/Va.
Manufactured by Omrix Biopharmaceuticals Ltd., based in Ramat Gan, Israel, Evithrom is made from pooled human plasma derived from U.S.-licensed plasma collection centers, using carefully screened donors. Johnson & Johnson Wound Management (a division of Ethicon Inc.) will be distributing it in the United States.
Evithrom contraindications include treatment of severe or brisk arterial bleeding.