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Valneva submits label extension application for chikungunya vaccine to FDA
The Fly

Valneva submits label extension application for chikungunya vaccine to FDA

Valneva (VALN) announced that it has submitted a label extension application to the U.S. Food and Drug Administration to potentially extend the use of its chikungunya vaccine IXCHIQ, which is currently approved in adults, to adolescents aged 12 to 17 years. “The application also includes adding the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ. This FDA application follows the submission of label extension applications to the European Medicines Agency and Health Canada two months ago,” the company noted.

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