World’s First Approved Chikungunya Vaccine
Valneva SE today announced that the U.S. Food and Drug Administration (FDA) approved IXCHIQ®, the Company’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. Valneva had received a Priority Review Voucher from the FDA.
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on November 9, 2023.
“Today’s approval addresses an unmet medical need and is an important advancement in preventing a potentially debilitating disease with limited treatment options.”
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.
The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.
Valneva will continue to evaluate antibody persistence for at least five years. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
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.
The Company will hold an analyst call and a webcast at 3:00 pm CET or 9:00 am EDT on November 13, 2023. The link will be available on the Company’s investor page.
Chikungunya outbreaks are primarily found in Africa, the Americas, Asia, and the Indian subcontinent. CHIKV outbreaks are related to other vaccine-preventable travel diseases, such as dengue, measles, and polio.
The U.S. CDC published Recommendations for Chikungunya Vaccine Use Among Adult Travelers on October 26, 2023.