Saint–Herblain (France), August 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, Valneva’s chikungunya virus vaccine candidate, from the previously communicated end of August to the end of November.
The FDA extended the PDUFA date to 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.
Valneva is committed to working with the FDA in its ongoing review of the BLA, and to potentially delivering the world’s first chikungunya vaccine. The Company reconfirms its previous guidance for potential BLA approval, initial launch, and potential award of a priority review voucher (PRV) still in 2023. This PDUFA extension does not impact Valneva’s current regulatory submission in Canada or its planned submission with the European Medicines Agency (EMA).
Juan Carlos Jaramillo, Chief Medical Officer of Valneva, said, “We appreciate and take pride in the fact that our BLA for VLA1553, if approved, will represent the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease, and hence the necessary Phase 4 activities will set a future standard. We are continuing to work closely and collaboratively with the FDA, and we believe it may be possible to obtain an approval before the new PDUFA date.”
About Valneva SE
We are a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases. We take a highly specialized and targeted approach to vaccine development by focusing on vaccine solutions addressing unmet medical needs to ensure we can make a difference to peoples’ lives. We apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, and our established vaccine development capabilities, to develop vaccines against diseases which are not yet vaccine-preventable, or for which there are limited effective treatment options. Today, we are leveraging our expertise and capabilities to rapidly advance a broad range of vaccines into and through the clinic, including candidates against Lyme disease, the chikungunya virus.
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