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FDA Approves Raplixa to Help Control Bleeding During Surgery
The FDA has given the green light to Raplixa (fibrin sealant [human], ProFibrix BV/The Medicines Group), the first spray-dried fibrin sealant to win agency approval.
Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels during surgery when standard techniques, such as suture, ligature, or cautery, are ineffective or impractical.
The two protein components of Raplixa –– fibrinogen and thrombin –– are individually purified using a manufacturing process that includes virus-inactivation and removal steps to help reduce the risk for transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended, and packaged in a vial. The product requires no thawing, reconstitution, or mixing and can be applied either directly from the vial or with the RaplixaSpray device. It is approved for use in conjunction with an absorbable gelatin sponge.
When applied to a bleeding site, Raplixa is dissolved in the blood, and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding.
“This approval provides surgeons an additional option to help control bleeding during surgery when needed,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “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.”
The FDA’s approval was based on data from an 11-month, phase III clinical study of 719 subjects undergoing vascular, hepatic, spinal, or soft-tissue surgery. The trial demonstrated that Raplixa used in conjunction with an absorbable gelatin sponge was superior in achieving hemostasis compared with the sponge alone as an adjunct to hemostasis.
The most common adverse events included postsurgical pain, nausea, constipation, fever, and hypotension.
Every year, approximately 2.6 to 3.0 million surgical procedures require the use of a topical hemostat product in the U.S., according to data from IMS Health.
Sources: FDA; April 30, 2015; and The Medicines Group; April 30, 2015.