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French specialty vaccine company Valneva (NASDAQ:VALN) announced on Monday that the European Medicines Agency (EMA) has accepted the marketing authorization application for its chikungunya vaccine for accelerated assessment.
The EU regulator determined that all essential regulatory elements required for scientific assessment were included in the application.
Valneva’s single-shot chikungunya vaccine candidate VLA1553 will go through an accelerated assessment, which reduces the timeframe for review from 210 days under the standard process to 150 days.
No vaccine or treatments currently exist for for chikungunya, making it an unmet medical need. VLA1553 was approved in the US earlier in November under the brand name Ixchiq.
Valneva also reported positive Phase 3 immunogenicity data that will support licensing the vaccine in Brazil, possibly the first approval for use in endemic populations.