November 10, 2023
Valneva's Ixchiq Receives FDA Approval: A Groundbreaking Advancement in Chikungunya Prevention
Valneva received approval from the US Food and Drug Administration (FDA) for Ixchiq, a single-dose, live-attenuated vaccine designed to prevent disease caused by the chikungunya virus (CHIKV) in individuals aged 18 and above who face an elevated risk of CHIKV exposure. This approval is granted under accelerated approval, contingent upon confirmation of clinical benefit in subsequent studies.
Ixchiq marks a significant milestone as the first-ever FDA-approved Chikungunya vaccine. The approval caters to individuals aged 18 and above who are at an increased risk of chikungunya virus exposure.
Chikungunya virus, primarily transmitted through mosquito bites, poses a growing global health threat, with over 5 million reported cases in the past 15 years. The highest risk is observed in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas. However, the virus has expanded to new areas, contributing to a rise in global prevalence.
Symptoms of chikungunya include fever and joint pain, with additional manifestations like rash, headache, and muscle pain. In some cases, individuals may suffer prolonged joint pain persisting for months or even years, necessitating rest, fluids, and over-the-counter medications.
Administered as a single dose via injection into the muscle, Ixchiq contains a live, weakened form of the chikungunya virus. It may induce symptoms similar to those experienced by individuals with chikungunya disease.
The FDA has mandated a postmarketing study to assess the serious risk of such adverse reactions post-Ixchiq administration.
Transmission of the chikungunya virus to newborns from pregnant individuals with viremia has been reported, potentially causing severe, fatal chikungunya virus disease. The vaccine's warning emphasizes the uncertainty regarding transmission risks from pregnant individuals to newborns and the potential adverse effects on newborns.
Healthcare providers considering administration to pregnant individuals should weigh the risk of chikungunya virus exposure, gestational age, and potential risks to the fetus or neonate.
Ixchiq's efficacy is rooted in immune response data from a US clinical study involving individuals aged 18 and above. Almost all participants achieved the antibody level considered protective in non-human primates. Accelerated approval is granted based on this evidence of effectiveness, with the FDA mandating confirmatory studies to verify clinical benefit.
Fast Track, Breakthrough Therapy designations, and Priority Review were awarded to Ixchiq, and the FDA granted a tropical disease priority review voucher to the manufacturer under the Food and Drug Administration Amendments Act of 2007.
With this FDA approval, Ixchiq stands as the world's first licensed chikungunya vaccine, addressing an unmet medical need and marking Valneva's third vaccine brought from early R&D to approval. The final Phase 3 data revealed a 98.9% seroresponse rate at 28 days with a single vaccination, and seroresponse was sustained over six months. Valneva will continue monitoring antibody persistence for at least five years.