Valneva's Ixchiq Chikungunya Vaccine Receives Us FDA Approval

Valneva SE, a company specializing in vaccines, has 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 in individuals aged 18 and older who are at higher risk of exposure to the virus.

This approval is granted through accelerated approval, which is based on anti-CHIKV neutralizing antibody titers. Approval for this indication remains subject to confirmation of clinical benefit in further studies.

Valneva, sponsor of the first chikungunya vaccine approved in the US, has been granted a Priority Review Voucher (PRV) from the FDA. The company plans to monetize the PRV to support its research and development (RandD) programs. Ixchiq has received US approval, making it the world's first licensed chikungunya vaccine to meet the unmet medical need. This marks the third vaccine developed by Valneva, starting from early RandD to approval. In March 2022, Valneva announced the final pivotal phase 3 data for the vaccine, revealing a 98.9% seroresponse rate at 28 days with just one vaccination. The company also reported final lot-to-lot consistency results in May 2022. The seroresponse generated by Ixchiq remained strong over time, with a 96.3% seroresponse rate six months after receiving the vaccination . Valneva plans to assess the persistence of antibodies for a minimum of five years. In June 2023, the pivotal phase 3 results of the company were released in the Lancet. More than 60 million Americans travel to countries where diseases transmitted by mosquitoes occur every year. Endemic species are those that are native and unique to a specific area. Ixchiq has been designed to cater to the needs of US travelers and seamlessly integrates into Valneva's well-established global travel vaccines business.