Posted by Michael Wonder on 13 Mar 2019
Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine
11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review of the company’s biologics license application for the liquid-frozen formulation of the MVA-BN smallpox vaccine will be extended by three months.
The application was granted a priority review in December 2018, originally targeting a six months review process. However, the FDA has assessed that due the amount of data submitted during the review phase, the agency now requires more time and has extended the target PDUFA action date to September 2019.
The application maintains priority review status with the FDA, and thus Bavarian Nordic would still be eligible to receive a priority review voucher when MVA-BN is approved.
