(Reuters) – Valneva announced on Friday that the U.S. Drug Administration (FDA) had approved its single-dose chikungunya vaccine for people aged 18 and older.
This is the first time in the world that a vaccine against this disease, transmitted by mosquitoes and which causes significant joint pain, has been authorized for marketing.
The French group, which becomes the first to have marketing authorization in the United States, has also filed an authorization request with the European Medicines Agency (EMA).
Valneva, which initially anticipated an FDA decision at the end of November, said it plans to begin selling the IXCHIQ vaccine in the United States early next year.
On the Paris Stock Exchange, Valneva shares climbed 9.1% to 6.88 euros at 10:42 a.m., after having climbed more than 13% earlier in the session, when the SBF120 lost 0.86% at the same time. .
In a note, analysts at RX Securities estimate that sales of the vaccine could peak at 160 million dollars (nearly 150 million euros), in the event of an agreement with the American army.
“We believe that Valneva is in a competitive position to seize this opportunity,” say Kempen analysts, who estimate peak sales at 250 million euros.
No antiviral treatment is available against chikungunya and until now the best way to protect against it has been to avoid mosquito bites.
According to the results of the IXCHIQ phase III trials, announced in March 2022 by Valneva, the sero-response rate was 98.9% at 28 days with a single vaccination. The sero-response was maintained over time with a rate of 96.3% six months after vaccination.
(Reporting by Augustin Turpin and Gaëlle Sheehan, edited by Kate Entringer and Blandine Hénault)
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