Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to the U.S. FDA
Valneva SE - American Depositary Shares (VALN)
Company Research
Source: GlobeNewswire
To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) 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 (EMA) and Health Canada two months ago1. These label extension applications are based on positive adolescent Phase 3 data, which the Company reported in May 20242. These data showed that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescen
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News
- Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India [Yahoo! Finance]Yahoo! Finance
- Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of IndiaGlobeNewswire
- Valneva Announces Peer-Reviewed Publication on the Global Health and Economic Burden of Chikungunya in The British Medical Journal [Yahoo! Finance]Yahoo! Finance
- Valneva Announces Peer-Reviewed Publication on the Global Health and Economic Burden of Chikungunya in The British Medical JournalGlobeNewswire
- Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® [Yahoo! Finance]Yahoo! Finance
VALN
Sec Filings
- 12/19/24 - Form 6-K
- 12/4/24 - Form 6-K
- 12/3/24 - Form 6-K
- VALN's page on the SEC website