Bavarian Nordic A/S' biologics license application for its smallpox vaccine has been granted a priority review by the U.S. Food and Drug Administration.
The Danish drugmaker sought approval from the regulatory body for the liquid-frozen version of MVA-BN for active immunization against smallpox in adults.
Under the priority review, the U.S. FDA will complete the assessment of the biologics license application in six months instead of the standard 10 months.
The biologics license application for MVA-BN is supported by the results of 22 clinical studies conducted under a comprehensive development program. Two late-stage studies have demonstrated that MVA-BN performs as well as Emergent BioSolutions Inc.'s ACAM2000, the current U.S. licensed vaccine for smallpox.
MVA-BN's unique ability to block the replication cycle of viruses contributes to its favorable safety profile and if approved, it will be the first and only nonreplicating smallpox vaccine in the U.S.
Bavarian will be eligible for a priority review voucher should MVA-BN be approved by the FDA. The company plans to sell the voucher, which can be used to accelerate the review process of a future biologics license application.
MVA-BN is already approved in Canada and the EU and is sold under the names Imvamune and Imvanex, respectively.
The company has already supplied 28 million doses of the liquid-frozen version of MVA-BN to the U.S. Strategic National Stockpile for emergency use in patients with compromised immune systems. Bavarian is under contract to replenish the stockpile, and plans to do so with a freeze-dried formulation. According to a Dec. 21 press release, Bavarian will start a phase 3 study to support the approval of the vaccine's freeze-dried formulation.