Sanofi Says FDA Agrees to Review Diabetes Drug Age Range - News Summed Up

Sanofi Says FDA Agrees to Review Diabetes Drug Age Range


An employee on a production line at a Sanofi site at Le Trait, southwestern France. - lou benoist/Agence France-Presse/Getty ImagesSanofi said the U.S. Food and Drug Administration accepted a priority review to potentially expand the current age range for its Tzield type-1 diabetes drug to include children as young as one year old. The French pharmaceutical company said Monday that the FDA’s review could amend the lower end of the range for the drug, which is currently approved for children as young as eight years old. The review comes after positive data from a Phase 4 study, and the anticipated action date for the FDA decision is April 29, Sanofi said. Write to Aimee Look at aimee.look@wsj.comMost Read from The Wall Street Journal


Source: Wall Street Journal January 05, 2026 14:45 UTC



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