Valneva (VALN) said Tuesday it has submitted a label extension application to the US Food and Drug Administration to expand the use of its chikungunya virus vaccine IXCHIQ to individuals between 12 and 17 years old.
The application also seeks to include two-year antibody persistence data on the product label, highlighting a key differentiator for IXCHIQ, which is currently approved for use in adults, the vaccine maker said.
The label extension application is based on positive phase 3 data from May, showing that a single dose of IXCHIQ produced a "high" and "sustained" immune response in 99.1% of adolescents, with the vaccine being generally well tolerated, Valneva said.
Shares of Valneva were down nearly 6% in recent Tuesday trading.
Price: 4.08, Change: -0.25, Percent Change: -5.77
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