CHMP positive recommendation for Ixchiq a Chikungunya vaccine – Valneva SE

Valneva SE a specialty vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.

The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application of Ixchiq in the European Union (EU), Norway, Liechtenstein and Iceland is expected in the third quarter of 2024. If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need. In accordance with the International Reliance Procedure (IRP), Valneva is also preparing a Marketing Authorization Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The CHMP opinion follows the November 2023 approval of Ixchiq by the US Food and Drug Administration (FDA)[1]. Two additional marketing authorization applications are currently under review by Health Canada and the Brazilian Health Regulatory Agency (ANVISA) with potential approvals in 2024.

The positive CHMP opinion is supported by data from the pivotal Phase III study which were published in The Lancet,(previously cited) the world’s leading peer-reviewed medical journal, and showed a 98.9% seroresponse rate at 28 days with a single vaccination. This robust vaccine response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults.

Earlier this month, Valneva reported further positive pivotal data in adolescents six months after a single vaccination, which are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years. The data are also expected to support licensure of Ixchiq in Brazil, which would be the first potential approval for use in an endemic population.