A product that contains a spray-dried, blended formulation of fibrinogen and thrombin, derived from human plasma, has been approved for use in helping control surgical bleeding, the Food and Drug Administration announced.

The approved indication for the fibrin sealant is for use with an absorbable gelatin sponge; it is the first spray-dried fibrin sealant approved by the FDA, according to its statement. The product, which will be marketed as Raplixa, can be applied from the product vial or sprayed onto the site of bleeding with a spray device.

“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” she added.

Approval was based on a study of 719 people undergoing different types of surgical procedures, which showed that use of the fibrin sealant with an absorbable gelatin sponge reduced the time required to achieve hemostasis, compared with the use of a sponge alone. The manufacturing process includes viral inactivation and removal to reduce the risk of transmitting of blood-borne viruses, the FDA statement said.

The approved indication is “to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical,” according to an April 30 statement issued by the Medicines Company. The statement said that the product does not need to be thawed, reconstituted or mixed before use, and it describes the spray device as “a low-pressure spray applicator designed to deliver Raplixa to larger bleeding surfaces in difficult to reach areas.”

The product is manufactured by ProFibrix BV, a subsidiary of the Medicines Company.



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