Emergent BioSolutions Inc. (NYSE:EBS) today announced the successful completion of the Mutual Recognition Procedure (MRP) for market authorisation 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 Authorisation of BioThrax in Germany granted by the Paul-Ehrlich-Institut. Following the positive MRP outcome, national licences are due to be issued shortly by the five CMS countries.
“Expanding the licence of BioThrax globally has been part of Emergent’s strategy and we are pleased with the completion of this process and the positive outcome of our application for market authorisation 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. For full details of EU prescribing information, please visit https://emergentbiosolutions.com/sites/default/files/inline-files/SmPC_EN v.11.5 03Apr2018_1.pdf
BioThrax is also licensed by the U.S. Food and Drug Administration for the active immunisation for prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age for both pre-exposure and post-exposure prophylactic use. For full U.S. prescribing information, please visit http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.
BioThrax is also licensed by the Singapore Health Sciences Authority.