Sanofi Says US FDA Issues Complete Response Letter For Secondary Progressive Multiple Sclerosis Treatment Application

MT Newswires Live2025-12-24

Sanofi (SNY) said Wednesday the US Food and Drug Administration has issued a complete response letter for its new drug application of tolebrutinib for the treatment of adult patients with non-relapsing secondary progressive multiple sclerosis.

Earlier this month, the drugmaker said the FDA review for tolebrutinib will be extended beyond the previously expected date of Dec. 28, with further guidance on the review process expected by the end of Q1 2026.

"Today's FDA decision is a significant and meaningful change in direction from the feedback the agency previously provided to Sanofi," the company said Wednesday. "We are very disappointed by the FDA's action."

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