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Valneva: positive opinion from the CHMP in chikungunya

( - On Friday evening Valneva announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion recommending marketing authorisation (MA) for its chikungunya vaccine in patients aged 18 and over.

This opinion is based on phase 3 data published in The Lancet, which showed a seroresponse rate of 98.9% at 28 days with a single vaccination. This robust immune response was maintained for 24 months by 97% of participants.

The European Commission will now examine the CHMP's recommendation for Ixchiq, with a decision on the marketing authorisation application in the European Union, Norway, Liechtenstein and Iceland expected in Q3 2024.

If approved, Ixchiq will become the first chikungunya vaccine available in Europe to address this unmet medical need. Valneva is also preparing a marketing authorisation application for submission to the UK MHRA.

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