FDA approves first spray-dried sealant to stop bleeding

FDA approved Raplixa (fibrin sealant [human]), used to help control bleeding during surgery, on April 30.

Manufactured by ProFibrix BV, a wholly owned subsidiary of The Medicines Company in Parsippany, N.J., Raplixa is the first spray-dried fibrin sealant approved by the agency.

Raplixa helps control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. 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,” according to an FDA statement.

Raplixa contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended and packaged in a vial.

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“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,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research.

Raplixa can be applied directly from the original product vial or by spraying with a delivery device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge.

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In support of approval, FDA reviewed data from a clinical study involving 719 participants over 11 months, undergoing different types of surgical procedures. The study demonstrated Raplixa’s effectiveness by comparing the reduction in the time needed for bleeding to stop when using this fibrin sealant and the time needed for bleeding to stop when using an absorbable sponge alone.

The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever and decreased blood pressure.

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