March 30, 2015 — The Medicines Company announced that the European Commission has granted marketing authorization for two acute care products – Kengrexal (cangrelor) and Raplixa (sealant powder). These approvals follow the issuance of positive opinions in January by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The marketing authorization for each of these products is now valid in the 31 countries of the European Economic Area (EEA), which includes all 28 European Union (EU) Member States, plus Norway, Iceland and Liechtenstein.
Kengrexal is a bioavailable, quickly reversible intravenous small molecule antiplatelet agent to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI). Raplixa is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical hemostatic product.
Prof. Philippe Gabriel Steg, M.D., director of the Coronary Care Unit, Hôpital Bichat-Claude Bernard, Paris, France, stated, “The availability of a potent, injectable, and reversible antiplatelet agent will be an important adjunct to our therapeutic armamentarium to reduce peri-procedural complications and help make PCI safer. It will be useful in a variety of settings from acute myocardial infarction to elective PCI, mostly in patients in whom antiplatelet agents have either not been administered or are known to be poorly effective.”
Prof. Wolf O. Bechstein, M.D., Ph.D., professor of surgery, Hospital of the Johann Wolfgang Goethe University, Frankfurt, Germany, noted, “I am pleased to see that Raplixa is approved throughout Europe. We were very fond of the product during the Phase 3B trial and look forward to using it in everyday practice. This will be an important new and innovative product for us to use in hemostasis treatment.”
The company used a centralized regulatory procedure, which allows applicants to obtain authorization for marketing throughout the EU, subject to national pricing and reimbursement processes. “Some member states such as England will allow marketing immediately,” said Stephanie Plent, M.D., executive vice president and chief value officer, The Medicines Company. “Other countries require pricing and reimbursement to be negotiated first, and that process is underway.”
Commercialization of each product will be directed by the company’s Global Innovation Groups, with European coordination via the company’s Zurich-based offices. The company will also begin finalizing logistics for product packaging and distribution channels for Europe. In addition, the company anticipates partnering with leading firms in Europe to provide the necessary field-based educational and promotional resources at a national and/or regional level.
A new drug application for Kengrexal (cangrelor) and a biologics license application for Raplixa are under active review by the U.S. Food and Drug Administration.
For more information: www.themedicinescompany.com