Valneva Completes Submission of Marketing Authorization Application to the FDA for its Chikungunya Vaccine Candidate











Photo credit © Valneva


(Boursier.com) — Valneva a company specializing in vaccines, announces today that it has completed the submission of its marketing authorization application file to the American health authority, the Food and Drug Administration (FDA), for its vaccine candidate single injection against chikungunya, VLA1553.
Valneva is seeking authorization for its experimental chikungunya vaccine in people aged 18 and over.

This marketing authorization application follows the final Phase 3 data announced in March 20221 and the final results of the clinical batch homogeneity trial announced in May 20222. A clinical study of VLA1553 in adolescents is in progress in Brazil3, in order to potentially allow future regulatory submissions regarding this age group if VLA1553 is authorized for use in adults. The Company also recently announced positive data on antibody persistence with a sero-response rate of 99% twelve months after a single injection of the vaccine.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented: “The completion of the submission of our marketing authorization application file is extremely important as it brings us closer to a possible preventive solution to combat this debilitating disease.Chikungunya is a major public health threat that is transmitted to humans by infected mosquitoes, and no vaccine or specific treatment for the disease is currently available.Subject to approval of the dossier by the FDA, our goal is to be able to provide a solution that can help reduce this growing and unmet medical need.”

The FDA will now review the submission for acceptance, decide whether the vaccine candidate is eligible for priority review, and indicate a target date for completing its review. The program received “Fast Track” and “Breakthrough Therapy” status from the FDA in 2018 and 2021, respectively. VLA1553 also received “PRIority MEdicine” (PRIME) status from the European Medicines Agency in 2020, and Valneva expects to file a marketing authorization application for VLA1553 in Europe in the second half of 2023.


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