Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) said on Wednesday 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.
The applications include two-year antibody persistence data.
IXCHIQ is currently approved for adults in the United States, Europe and Canada. Valneva expects to submit data to the US Food and Drug Administration (FDA) this year to support potential label extensions in the United States. The company is also focused on expanding the vaccine's label and access in other regions, including Brazil.
The label extension applications are based on positive six-month adolescent Phase 3 data. Valneva expects to publish 36-month persistence data later this year.
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