The Medicines Company has announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, 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 (PDUFA date) for Fibrocaps is January 31, 2015.
In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and Western Europe, met all of its primary and secondary hemostasis efficacy endpoints in each of four distinct populations: (1) spinal surgery; (2) hepatic resection; (3) soft tissue dissection; and (4) 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. Our previously announced EMA filing also suggests that Fibrocaps can be our first hemostat product in the European market," said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company.
"With the acceptance of the Fibrocaps BLA we now have 6 new molecular entity regulatory submissions under review at the FDA and the EMA," said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. "These applications span our three areas of focus in leading hospitals, namely: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. Each is designed to contribute to our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on the needs of leading hospitals worldwide."