EU approves Raplixa (sealant powder) for Haemostasis- The Medicines Co.

The European Commission has granted marketing authorization for Raplixa (sealant powder), from The Medicines Co., for use as a haemostatic agent in surgical bleeding encountered during spinal, vascular, liver and soft tissue surgery where conventional surgical techniques are ineffective or impractical. A biologics license application for Raplixa is under active review by the FDA.

The Marketing Authorization Application (MAA) submission for Raplixa (formerly known as Fibrocaps) to the EMA was based on a pivotal Phase III clinical trial, FINISH-3. FINISH-3 is an international, randomized, single-blind, controlled trial that compared the efficacy and safety of Raplixa, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen with gelatin sponge, vs. gelatin sponge alone for use as a hemostat for surgical bleeding in four indications (spinal, hepatic, vascular, soft tissue dissection). The Phase III trial, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, vascular surgery and soft tissue dissection.

The most commonly reported adverse events (>5%) in patients treated with Raplixa were nausea, constipation, post-operative pain, hypokalemia, pyrexia, and low blood pressure, with the majority considered mild in intensity.