FDA approves Raplixa (fibrin sealant) and Raplixa Spray to control bleeding-The Medicines Company.

The Medicines Company announced the FDA has approved Raplixa (fibrin sealant) and the Ralpixa Spray device 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 IMS data, it is estimated that every year, approximately 2.6 – 3 million surgical procedures require the use of a topical hemostat product in the U.S.

The approval of Raplixa was based on one large Phase III, multicenter clinical trial involving 721 patients in four countries. This trial demonstrated that Raplixa used in conjunction with an absorbable gelatin sponge was superior in achieving hemostasis as compared to treatment with sponge alone when used as an adjunct to hemostasis in patients undergoing vascular, hepatic, spinal, and soft tissue surgery. Adverse events were generally similar between treatment groups and consistent with those observed in patients undergoing surgery.

Comment: Raplixa was approved in the EU in March 2015. Sales estimates are $300 million a year.