Primary progressive multiple sclerosis BTK inhibitor FDA approval with brain-penetrant therapy treatment
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Sanofi Receives FDA Approval for Tolebrutinib in Primary Progressive Multiple Sclerosis

Sanofi announces FDA approval of tolebrutinib for adults with primary progressive multiple sclerosis, expanding its MS indications.

Sanofi today announced that the FDA has approved tolebrutinib for the treatment of adults with primary progressive multiple sclerosis (PPMS). In the Phase 3 PERSEUS trial, tolebrutinib demonstrated a statistically significant reduction in the risk of 6-month confirmed disability progression compared to placebo. This approval expands tolebrutinib's MS indications to include PPMS in addition to nrSPMS, making it the first BTK inhibitor approved across multiple progressive MS forms. Tolebrutinib is a brain-penetrant BTK inhibitor targeting both peripheral immune cells and CNS-resident microglia.

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