VALN - Valneva starts rolling submissions for FDA approval of chikungunya vaccine

• French vaccine maker Valneva ( NASDAQ: VALN ) announced Thursday that the company initiated the rolling submission of a Biologics License Application (BLA) to the FDA, seeking the U.S. regulatory nod for its single-shot chikungunya vaccine candidate.
• The BLA aimed at those aged 18 years and above is based on final pivotal trial data reported in March and final lot-to-lot consistency results disclosed in May, VALN said.
• The company added that an ongoing clinical trial for the vaccine named VLA1553 involving adolescents in Brazil could support future regulatory submissions for this age group subject to approval for adults.
• VALN expects to complete the BLA submission at the end of the year and anticipates European regulatory submissions for VLA1553 in 1H 2023.
• According to topline data from the late-stage trial, VLA1553 reached the primary endpoint generating protective CHIKV neutralizing antibody titers in 98.5% of trial participants.

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