FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease caused by Chikungunya Virus
Valneva SE, a specialty vaccine company, has announced that the U.S. Food and Drug Administration (FDA) has approved Ixchiq®. Valneva’s single-dose, live-attenuated vaccine is 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.
Every year, more than 60 million Americans travel to countries where mosquito-borne diseases are endemic. Initially addressing the potential needs of U.S. travelers, Ixchiq® fits seamlessly into Valneva’s global established travel vaccines business.
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.
