Valneva SE, a specialty vaccine company, announced that the U.S. Food and Drug Administration (FDA) has approved IXCHIQ, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.
With this U.S. approval, IXCHIQ becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva has brought from early R&D to approval. Valneva reported final pivotal Phase 3 data for the vaccine in March 2022 showing a 98.9% seroresponse rate at 28 days with a single vaccination and final lot-to-lot consistency results in May 2022. IXCHIQ-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination. Valneva will continue to evaluate antibody persistence for at least five years. The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.