Valneva Seeks Approval To Expand IXCHIQ Chikungunya Vaccine Use To Adolescents In Europe And Canada

(RTTNews) - Valneva SE (VALN) said 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 said it 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.

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.

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.