Medicines Co. Says FDA Accepts BLA For Fibrocaps - Quick Facts

(RTTNews) - The Medicines Co. (MDCO) Thursday said the U.S. Food and Drug Administration accepted the filing of a biologic license application or BLA for the investigational hemostatic agent Fibrocaps.

Fibrocaps is a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. The FDA action date, the PDUFA date, for Fibrocaps is January 31, 2015.

In August 2013, the company announced that the Phase III trial, FINISH-3, which studied 719 patients across 54 sites in the U.S. and Western Europe, met all its primary and secondary hemostasis efficacy endpoints in each of four distinct populations: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery.

"We believe Fibrocaps has the potential to become an important hemostatic product -- complementary to Recothrom Thrombin, topical (Recombinant) -- which will allow us to continue to serve leading US hospitals, leveraging our existing operations," said Adam Sharkawy, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company.

With the acceptance of the Fibrocaps BLA, the company now has 6 new molecular entity regulatory submissions under review at the FDA and the EMA.