“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. For full details of EU prescribing information, please visit https://emergentbiosolutions.com/sites/default/files/inline-files/SmPC_EN%20v.11.5%2003Apr2018_5.pdf.
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. 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.
BioThrax is the only anthrax vaccine licensed by the U.S. Food and Drug Administration, Singapore Health Sciences Authority, and the German Paul-Ehrlich-Institut, for the prevention of anthrax disease. The safety and efficacy of BioThrax have not been established in pediatric or geriatric populations. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.
BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Over 14 million doses of BioThrax have been administered to more than 3 million individuals.