Bavarian Nordic Announces FDA Acceptance and Priority Review of the BLA for its Chikungunya Vaccine
Wednesday, August 14, 2024
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for CHIKV VLP, the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older.
The Priority Review designation means the FDA is targeting completion of its review within six months, compared to 10 months under standard review, and thus has assigned a Prescription Drug User Free Act (PDUFA) target action date of February 14, 2025.
“We are encouraged by the FDA’s decision to grant Priority Review to our chikungunya vaccine, allowing for a shorter review time, and we look forward to working closely with the regulators to make our vaccine available to individuals 12 years of age and older at risk of chikungunya virus infection. The FDA review, along with the ongoing review of our CHIKV VLP vaccine by EMA, represent the first regulatory reviews of a chikungunya vaccine for adolescents, potentially providing a broader usage by populations at risk of this debilitating disease,” said Paul Chaplin, President and CEO of Bavarian Nordic.
CHIKV VLP is currently also under accelerated assessment review with the European Medicines Agency (EMA), potentially supporting approval of the vaccine by the European Commission in the first half of 2025.
Source: globenewswire.com
