The US Food and Drug Administration (FDA) has a revised Prescription Drug User Fee Act (PDUFA) action date of November 2023 for Valneva’s chikungunya vaccine, VLA1553.
As per Valneva, the PDUFA date extension of three months, from the end of August to the end of November, provides time to plan an FDA-approved Phase IV clinical programme. In light of the delay, Valneva’s stock saw a flurry of trade activity, with more than a million shares being traded, and the stock being down by 7.5% at the Euronext Paris when the market opened today, compared to the market close on Friday.
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VLA1553 is a live-attenuated vaccine, that allows for active immunisation of the mosquito-borne viral disease, chikungunya. The vaccine is under priority review by the FDA. Its development was partly funded by $24.6m awarded by the Coalition for Epidemic Preparedness Innovations (CEPI) to Valneva.
The published Phase III trial (NCT04546724) results reported a 98.9% seroresponse rate with the vaccine 28 days after the first injection. Additionally, the vaccine was well tolerated, with only 1.5% of treatment group participants reporting any serious adverse events, compared to 0.8% in the placebo group.
Valneva’s chikungunya vaccine is expected to be a blockbuster drug in the field, with GlobalData forecasting $248m in global sales for the vaccine in 2029.
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By GlobalDataOther chikungunya vaccines that are in Phase III clinical development include Bavarian Nordic’s virus-like particle vaccine and Bharat Biotech’s inactivated virus vaccine.
Valneva chief medical officer Juan Carlos Jaramillo said: “We appreciate and take pride in the fact that our [biologics licence application] BLA for VLA1553, if approved, will represent the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease, and hence the necessary Phase IV activities will set a future standard.
“We are continuing to work closely and collaboratively with the FDA, and we believe it may be possible to obtain approval before the new PDUFA date.”
