FDA Accepts The Medicines Company's BLA For Fibrocaps Anti-Bleeding Agent
By Cyndi Root
The Medicines Company announced in a press release that the Food and Drug Administration (FDA) has accepted the application for Fibrocaps. The investigational hemostatic agent is a formulation of fibrinogen and thrombin indicated for bleeding control during surgery. The FDA will take action on the biologic license application (BLA) by January 31, 2015. Adam Sharkawy, SVP at The Medicines Company said, "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 U.S. hospitals, leveraging our existing operations.”
Surgical Hemorrhage
Surgical hemorrhages are common and associated with mortality. Early intervention is often critical to control bleeds and save the patient’s life. Hemostatic sealants can help the blood to coagulate or mechanically seal the hemorrhage. In many cases, the application of some agents is difficult or contraindicated.
Fibrocaps
Fibrocaps is indicated for aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. Fibrocaps, the proposed name, is a dry powder formulated with fibrinogen and thrombin. The Medicines Company had previously agreed to purchase FibroCaps in the ProFibrix line based on results of a Phase III trial. In August of 2013, due to positive results, The Medicines Company completed the purchase of ProFibrix for $90 million. The company must also pay ProFibrix equity holders milestone payments upon U.S. and European regulatory approvals.
FDA Action
The federal agency based its application approval on studies conducted in the U.S. and abroad. Results showed rapid action against bleeding with reductions in the amount of time to reach hemostasis. No adverse events were reported. Clive Meanwell, Chairman and CEO of The Medicines Company said, "With the acceptance of the Fibrocaps BLA we now have 6 new molecular entity regulatory submissions under review at the FDA and the EMA.”
About The Medicines Company
The Medicines Company was founded in 1996 and is headquartered in Parsippany, NJ employing over 400 people. The company markets FDA approved Angiomax (bivalirudin) for Injection, Cleviprex (clevidipine) Injectable Emulsion, and Argatroban Injection. Late-stage agents include cangrelor, oritavancin, and MDCO-157.