Sanofi’s Tzield Gets US Priority Review For Young Children

Sanofi announced the US Food and Drug Administration has accepted for priority review its application to expand Tzield’s age indication to children as young as one year old to delay the onset of stage 3 type 1 diabetes.

• FDA set target action date of April 29
• Application supported by positive interim data from PETITE-T1D phase 4 study
• Tzield slows disease progression by protecting insulin-secreting beta cells
• NOTE: Drug already approved for patients eight years and older
• Priority review granted for therapies with potential significant treatment improvements

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