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Sanofi Says FDA Agrees to Review Diabetes Drug Age Range

Provided by Dow Jones Jan 5, 2026, 6:40:00 AM

By Aimee Look

Sanofi 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.

Tzield would be the first disease-modifying therapy that works to delay stage three type-1 diabetes for children aged one and older--who currently have stage two of the disease, according to Sanofi.

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.com

(END) Dow Jones Newswires

January 05, 2026 01:40 ET (06:40 GMT)

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