Pharmaceutical Technology

Daily Newsletter

13 November 2023

Daily Newsletter

Valneva wins FDA approval for the first chikungunya vaccine

Following the three-month FDA review delay, Valneva’s live-attenuated chikungunya vaccine, Ixchiq, received accelerated approval.

The US Food and Drug Administration (FDA) has granted accelerated approval to the first chikungunya vaccine, Valneva’s Ixchiq.

Ixchiq is a single-dose live-attenuated vaccine which has been approved for preventing chikungunya viral disease in adults, aged 18 years and older. The vaccine development was partly funded by a $24.6m award from the Coalition for Epidemic Preparedness Innovations (CEPI).

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus which is transmitted by Aedes mosquitoes. According to the World Health Organization (WHO), chikungunya is prevalent in Africa, Asia, and the Americas.

Valneva has also applied for marketing approval for Ixchiq in Canada and Europe. The chikungunya vaccine is forecasted to generate $344m in global sales in 2029, as per GlobalData analysis.

GlobalData is the parent company of Pharmaceutical Technology.

The FDA approval for the vaccine was based on the immune response data from the Phase III trial (NCT04546724). Of the 266 trial participants, 263 showed neutralising antibody levels 28 days post-vaccination following a single vaccination with Ixchiq, irrespective of age.

Commonly observed vaccine-related side effects include headache, fatigue, and tenderness at the injection site, among others.

Ixchiq’s continued approval is contingent on the FDA-required post-marketing study to assess “the serious risk of severe chikungunya-like adverse reactions” post-Ixchiq administration, as per a 9 November press release. The FDA pushed the Prescription Drug User Fee Act (PDUFA) for Ixchiq by three months to November 2023 to “allow sufficient time to align and agree” on a post-marketing trial, based on a 14 August press release.

Valneva is also evaluating Ixchiq in the paediatric population. The Phase III trial (NCT04650399) evaluating the chikungunya vaccine in adolescents, aged 12-17 years, is currently underway. In August, the company shared positive initial safety data from the trial that showed that the vaccine was well tolerated. The French company also received a Priority Review Voucher from the FDA.

Valneva plans to sell the voucher to finance its research and development (R&D) programmes, as per a 10 November press release.

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