Emergent BioSolutions completes BioThrax Mutural Recognition Procedure in Europe
Emergent BioSolutions completed the Mutual Recognition Procedure for market authorization of BioThrax in five Concerned Member States within the European Union, including Italy, the Netherlands, Poland, the U.K., and France. 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. Where approved in Europe, BioThrax is indicated for prevention of disease caused by Bacillus anthracis in adults at risk of exposure. BioThrax is also licensed by the FDA for the active immunization for the prevention of disease caused by Bacillus anthracis.