Emergent BioSolutions Inc. announced this week the successful completion of the Mutual Recognition Procedure (MRP) for market authorization of BioThrax® (Anthrax Vaccine Adsorbed) in five Concerned Member States (CMS) within the European Union (EU), including Italy, the Netherlands, Poland, the U.K., and France (where it will be marketed as BaciThrax™).
Emergent filed the mutual recognition application based on the existing Marketing Authorization of BioThrax in Germany granted by the Paul-Ehrlich-Institut. Following the positive MRP outcome, national licenses are due to be issued shortly by the five CMS countries.
“Expanding licensure of BioThrax globally has been part of Emergent’s strategy and we are pleased with the completion of this process and positive outcome of our application for market authorization in these member states,” said Adam Havey, executive vice president, business operations at Emergent BioSolutions. “With the heightened awareness of the need to protect militaries and civilians against public health threats, we are proud to be able to support allied governments with preparedness solutions that align with their national security plans. Based on this regulatory approval, we look forward to further expanding our footprint within the EU.”
Where approved in Europe, BioThrax is indicated for prevention of disease caused by Bacillus anthracis in adults at risk of exposure. BioThrax is administered in a three-dose primary schedule (0, 1 and 6 months) with boosters at three-year intervals recommended thereafter.
BioThrax is also licensed by the U.S. Food and Drug Administration for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age for both pre-exposure and post-exposure prophylactic use
BioThrax is also licensed by the Singapore Health Sciences Authority.