VALN - Valneva's single-shot chikungunya vaccine VLA1553 gets FDA priority review
- The U.S. Food and Drug Administration (FDA) granted priority review to Valneva ( NASDAQ: VALN ) application seeking approval of single-shot chikungunya vaccine candidate VLA1553.
- The FDA accepted the company's biologics license application (BLA) and is expected to make a decision by end of August.
- Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
- Earlier in February, the French drugmaker had said that it completed enrollment and vaccination in a phase 3 trial, dubbed VLA1553-321, of the chikungunya vaccine in adolescents and the results are expected in mid-2023.
- Chikungunya virus is spread to people via the bite of an infected mosquito.
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Valneva's single-shot chikungunya vaccine VLA1553 gets FDA priority review