FDA accepts Sanofi's filing for MS drug Tolebrutinib, showing efficacy in delaying disability progression

From Nasdaq: 2025-03-26 02:06:00

Sanofi’s FDA filing for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) has been accepted, with a final decision expected by Sept. 28, 2025. Data supports the drug’s efficacy in delaying disability progression. Tolebrutinib targets smoldering neuroinflammation, addressing a significant unmet need in MS.

Sanofi is also evaluating tolebrutinib in primary progressive MS. The drug was acquired in 2020. FDA placed a partial clinical hold on phase III studies due to liver injury cases. MG studies were discontinued in 2022. Sanofi currently holds a Zacks Rank #3 (Hold).

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Read more at Nasdaq: FDA Accepts Sanofi’s Filing for Multiple Sclerosis Drug Tolebrutinib (Revised)