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news.The Medicines Company has announced that the US 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.
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The FDA action date (PDUFA date) for Fibrocaps is 31 January 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 US 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.
The Medicines Company senior vice president and surgery and perioperative care global innovation group leader Dr Adam Sharkawy noted that the company believes 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," Dr Sharkawy added.