Emergent BioSolutions Announces Successful Completion of Mutual Recognition Procedure for Market Authorisation of BioThrax in European Countries
- Category: Vaccines
- Published on Sunday, 15 April 2018 13:38
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GAITHERSBURG, MD USA I April 12, 2018 I 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%20v.11.5%2003Apr2018_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.
BioThrax is the only anthrax vaccine licensed by the U.S. Food and Drug Administration, the Singapore Health Sciences Authority, and Germany’s Paul-Ehrlich-Institut, for the prevention of anthrax disease. The safety and efficacy of BioThrax have not been established in paediatric or geriatric populations. Individuals are not considered protected until they have completed the three-dose primary immunisation 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.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.
SOURCE: Emergenzt BioSolutions