27.11.2023 07:19:21
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Valneva Reports EMA's MAA Review Acceptance For Chikungunya Vaccine Candidate VLA1553
(RTTNews) - Valneva SE (VALN) announced that the European Medicines Agency has performed a technical validation of the Marketing Authorization Application for the company's single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements required for scientific assessment were included in the application. The MAA was granted accelerated assessment last month by EMA's Committee for Medicinal Products for Human Use. The accelerated assessment reduces the timeframe for EMA's CHMP to review a MAA once it is accepted for review from 210 days to 150 days.
The company noted that VLA1553 received approval from the FDA at the beginning of the month under the brand name IXCHIQ.
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