FDA accepts application for the liquid-frozen version of the MVA-BN for active immunization against smallpox in adults age 18 years and older. Bavarian Nordic

Bavarian Nordic A/S announced that the 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 regulatory submission for the MVA-BN smallpox vaccine is based on a comprehensive development program, comprising 22 clinical studies, including two Phase III studies, the latter of which showed non-inferiority of MVA-BN compared to ACAM 2000, the current U.S. licensed, replicating smallpox vaccine. In addition, no serious adverse events related to MVA-BN were reported, and the frequency of Grade 3 or higher related adverse events was less in MVA-BN (1.2%) in comparison to the replicating smallpox vaccine (10.3%).

If approved, Bavarian Nordic would also be eligible to receive a Priority Review Voucher, which provides incentives to developers of medical countermeasures among others. The voucher can be used to accelerate the review of a future BLA and is also transferrable. The Company intends to sell the voucher to a third party.