European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Fibrocaps

PARSIPPANY, NJ--(Nov 21, 2013) - The Medicines Company (MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational hemostatic agent Fibrocaps (human plasma-derived fibrinogen and thrombin). Fibrocaps was studied in the 719-patient Phase III FINISH-3 clinical trial as an adjunct to hemostasis in patients undergoing surgical procedures when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical. The acceptance of the MAA marks the beginning of the review process in the European Union for Fibrocaps. The Company anticipates submitting a biologics license application (BLA) with the United States Food and Drug Administration in the first quarter of 2014. The Company also plans to submit a 510(k) application with the FDA for the complementary spray delivery device to assist surgeons in the accurate application of the dry powder Fibrocaps. The device was recently granted a European CE mark. "We believe Fibrocaps can become an important hemostatic solution within our surgery and perioperative care portfolio upon regulatory approval," said Jan Ohrstrom, MD, Senior Vice President Global Launch Leader, Hemostasis Solutions of The Medicines Company. "We are expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare."About The Medicines CompanyTh...
Source: Medical Hemostat - Category: Technology Consultants Authors: Source Type: blogs