(Reuters) – French drugmaker Valneva said on Monday that the marketing authorization application for its chikungunya vaccine candidate has been accepted by the European Medicines Agency (EMA) which will now review the medicine under an accelerated procedure.
The EMA “concluded that all essential regulatory elements required for the scientific evaluation have been included in the application,” Valneva said in a statement.
Analysts say the news is in line with their expectations, with RX Securities forecasting a decision in the second half of 2024.
The accelerated assessment reduces the review time by the EMA from 210 days to 150 days, depending on the laboratory.
On the Paris Stock Exchange, the group’s shares rose by around 2% in the morning, surpassing the SBF120 index which fell by 0.1%.
The VLA1553 vaccine against chikungunya, a viral disease transmitted by mosquitoes, was approved by the US drug regulator (FDA) in November.
Valneva also announced in November positive pivotal Phase 3 results in adolescents regarding the immunogenicity of this vaccine, a trial which should allow its approval in Brazil.
(Reortage Olivier Sorgho; Dagmarah Mackos, edited by Kate Entringer)
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