The first human thrombin approved since 1954 will soon be available. Evithrom received approval of its Biological License Application by the FDA.
The topical thrombin is plasma-derived from human donors and has been given a regulatory nod as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules are accessible, and control of bleeding by standard surgical techniques is ineffective or impractical. Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation & Research, said, "The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding. Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma."
The immunogenicity of Evithrom was evaluated by testing for the development of antibodies to highly purified antigens. Findings showed none of the patients treated with Evithrom developed antibodies to human thrombin or human factor V/Va, an advantage that is likely to give Evithrom rapid market share gain, according to market analysts.
Topical use only
Evithrom was approved to be used alone or in combination with an absorbable gelatin sponge and is for topical use only. The amount of product necessary depends on the area of tissue to be treated and the method of application. In clinical studies, a dose of up to 10 ml was used in combination with an absorbable sponge.
Prior to application, the target surface area should be sponged free of blood. The affected area should then be flooded with Evithrom, using a sterile syringe and a single-gauge needle. Subsequent sponging of the clot should be avoided to ensure that it remains securely in place.
According to the prescribing information, Evithrom will be supplied as a frozen solution in 2-, 5-, or 20-ml vials. Each vial contains 800 to 1,200 IU/ml of topical human thrombin. The frozen product can be stored in the freezer for up to two years but must be thawed prior to use. Evithrom will thaw in the refrigerator within one day, and within one hour at room temperature. In addition, the 2-ml and 5-ml vials will thaw at a temperature of 37°C within 10 minutes. According to J&J Wound Management, the company will begin distribution of Evithrom in the fourth quarter.
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