Valneva’s Single-Dose Vaccine IXCHIQ® Receives FDA Approval for Chikungunya Prevention
The U.S. Food and Drug Administration (FDA) has granted approval to Valneva’s single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals aged 18 and older. This marks a significant step in addressing the unmet medical need for a chikungunya vaccine.
The approval was granted under the FDA’s accelerated approval program, which relies on anti-CHIKV neutralizing antibody titers. Continued approval is contingent upon verification of clinical benefit in confirmatory studies. Valneva, a specialty vaccine company, will be discussing the FDA approval during an analyst call and webcast scheduled for November 13, 2023.
As the sponsor of the first chikungunya vaccine approved in the U.S., Valneva has also received a Priority Review Voucher (PRV) from the FDA. The company plans to monetize this voucher to support its research and development (R&D) programs. This will allow Valneva to continue its efforts in advancing innovative vaccines and addressing unmet medical needs.
IXCHIQ® not only becomes the world’s first licensed chikungunya vaccine but also represents the third vaccine that Valneva has successfully brought from early R&D to approval. The vaccine has shown promising results in its Final Phase 3 data. With a single vaccination, it demonstrated a 98.9% seroresponse rate at 28 days, which remained sustained over time. Six months post-vaccination, the seroresponse rate was 96.3%. Valneva is committed to evaluating the vaccine’s antibody persistence for at least five years.
The Phase 3 results of Valneva’s vaccine were published in the Lancet in June 2023, further highlighting the efficacy and potential of IXCHIQ® in preventing chikungunya. This approval represents a significant advancement in efforts to combat the chikungunya virus and protect individuals at risk of infection.
Valneva’s dedication to vaccine development and its expertise in addressing medical needs have led to this groundbreaking achievement. With the approval of IXCHIQ®, there is renewed hope in the fight against chikungunya, bringing us one step closer to a safer and healthier future.