FDA Extends PDUFA Date For Valneva's Chikungunya Virus Vaccine Candidate

(RTTNews) - Valneva SE (VLA) said Monday that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act or PDUFA action date for the Biologics License Application or BLA for the company's chikungunya virus vaccine candidate, VLA1553, from the previously communicated end of August to the end of November.

The PDUFA extension will allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval pathway. No additional clinical data have been requested for the approval process, the company said in a statement.

Valneva reconfirmed its previous guidance for potential BLA approval, initial launch, and potential award of a priority review voucher still in 2023. The PDUFA extension does not impact the company's current regulatory submission in Canada or its planned submission with the European Medicines Agency.

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