Valneva: submits US marketing authorisation for chikungua

(CercleFinance.com) - Valneva has announced that it has completed the submission of its New Drug Application (NDA) to the US FDA for its single-injection chikungunya vaccine candidate, VLA1553, in people aged 18 years and older.


The filing follows final Phase 3 data that was announced in March 2022 and final results from the clinical lot consistency trial announced in May. A study in adolescents is underway in Brazil.

The FDA will review the dossier for acceptance, rule on the vaccine candidate's eligibility for priority review, and provide a target date for completion of its evaluation. Valneva also plans to file for marketing approval in Europe in H2 2023.


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