Photo by Piotr Bodzek
The US Food and Drug Administration (FDA) has approved the first spray-dried fibrin sealant to help control bleeding during surgery.
The agency approved Raplixa (formerly known as Fibrocaps) for use in adults to control bleeding from small blood vessels when standard surgical techniques are ineffective or impractical.
The standard techniques include suture, ligature, or cautery.
Raplixa contains fibrinogen and thrombin, proteins found in human plasma. When the surgical team applies Raplixa to the bleeding site, the sealant dissolves in the blood, and the fibrinogen and thrombin proteins react, resulting in the formation of blood clots.
The 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.
Raplixa can be applied directly from the original product vial or by spraying it with a delivery device. Raplixa is used in conjunction with an absorbable gelatin sponge.
“The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial,” said Karen Midthun, MD, of the FDA’s Center for Biologics Evaluation and Research.
“This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.”
Raplixa was approved for use in the European Union in March, based on the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Phase 3 trial
The FDA approved Raplixa based on data from the FINISH-3 trial, a randomized, single-blind, controlled, phase 3 study of 719 patients undergoing spinal surgery (n=183), hepatic resection (n=180), vascular surgery (n=175), or soft tissue dissection (n=181) in 4 countries over 11 months.
As reported in the Journal of the American College of Surgeons, adults with mild or moderate surgical bleeding were randomized to recieve Raplixa or the gelatin sponge. Researchers recorded the time to hemostasis over 5 minutes within each surgical indication.
Four hundred and eighty patients were treated with Raplixa, and 239 were treated with the gelatin sponge. Surgeons used the spray device in 53% of Raplixa procedures.
Raplixa used in conjunction with the gelatin sponge significantly reduced time to hemostasis compared to the gelatin sponge alone (P<0.001 for each of the 4 sugical indications).
Raplixa also significantly reduced median time to hemostasis for each indication (P<0.0001).
Adverse events were similar between the treatment arms. The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever, and decreased blood pressure.
Two percent of Raplixa-treated patients developed non-neutralizing anti-thrombin antibodies, as did 3% of patients treated with the gelatin sponge.
Raplixa is manufactured by ProFibrix BV, a wholly owned subsidiary of The Medicines Company, based in Parsippany, New Jersey.
