FDA delays PDUFA date for Valneva's chikungunya vaccine

The US Food and Drug Administration (FDA) has a revised Prescription Drug User Fee Act (PDUFA) action date from August to November 2023 for French company Valneva’s (Euronext Paris: VLA) chikungunya vaccine, VLA1553, with the news pushing its shares down as much as 7.5%.

The FDA extended the PDUFA date to allow sufficient time to align and agree on the Phase IV program necessary under the accelerated approval pathway. No additional clinical data have been requested for the approval process.

Valneva’s chikungunya vaccine is expected to be a blockbuster drug in the field, with GlobalData forecasting $248 million in global sales for the vaccine in 2029. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032.