Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ, to EMA and Health Canada

Valneva SE, a specialty vaccine company, announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ, to adolescents aged 12 to 17 years in Europe and Canada. The Canadian label extension application also includes two-year antibody persistence data, which is a key differentiator for IXCHIQ that was already included in the initial EMA filing. Valneva expects to submit data to the U.S. Food and Drug Administration (FDA) this year to also support potential label extensions in the U.S.

IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S., Europe, and Canada for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The U.S. launch is underway while first sales in Canada and Europe are anticipated in the fourth quarter of 2024.

In addition to ramping up sales, Valneva is focused on expanding the vaccine’s label and access. The Company expects a marketing authorization in Brazil in the second half of 2024 and recently expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) to support broader access to the vaccine in Low Middle-Income Countries (LMICs), post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe program.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups. This broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected. The durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.”

EMA and Health Canada’s label extension applications are based on positive six-month adolescent Phase 3 data which the Company reported in May 2024. These data showed that a single-dose vaccination with IXCHIQ induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated. The Lancet Infectious Diseases, a world leading infectious diseases journal, also recently published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous CHIKV infection.

In addition to the adolescent data, Health Canada’s label extension application included IXCHIQ‘s antibody persistence data which showed that the vaccine’s immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults. The Company expects to publish 36 months persistence data later this year.