Bavarian Nordic: FDA Priority Review of Application for Smallpox Vaccine

Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the liquid-frozen version of the MVA-BN for active immunization against smallpox in adults age 18 years and older. The FDA has granted priority review to the BLA, which means that the agency is targeting completion of the review in six months rather than the standard time of ten months. Priority review is granted by the FDA to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. If approved, MVA-BN would be the first and only approved non-replicating smallpox vaccine in the U.S.

“The acceptance of our BLA is a significant milestone for Bavarian Nordic, and for our long-standing collaboration with the U.S. Government on the development of MVA-BN to address public health threats, such as smallpox,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “While MVA-BN has already been approved in the EU and in Canada, an FDA approval would represent an important acknowledgment of our core platform technology, which we are actively investigating across multiple infectious disease and cancer indications.”

https://www.marketscreener.com/BAVARIAN-NORDIC-A-S-1412846/news/Bavarian-Nordic-A-S-Announces-FDA-Acceptance-and-Priority-Review-of-Biologics-License-Application-27792558/