Valneva: an MA dossier deemed admissible by Health Canada


(CercleFinance.com) – Valneva announces that Health Canada has completed the admissibility review of the marketing authorization application (MA) for its single-shot chikungunya vaccine candidate VLA1553 for use in 18-year-olds and more.

The regulatory agency deemed the dossier sufficiently complete to allow for a substantive review of the data submitted. Based on the usual processing times for its authorization applications, the regulatory review should be completed by mid-2024.

This is the second regulatory application for VLA1553 filed by Valneva, and the company intends to file more in 2023. An MA application is currently undergoing priority review by the FDA the United States.

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