FDA status for Sanofi’s tolebrutinib in non-relapsing secondary progressive MS
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
Sanofi’s (Euronext; SAN) Bruton’s tyrosine kinase (BTK) inhibitor is being evaluated in Phase III studies for the treatment of various forms of multiple sclerosis.
This is based on positive results from the HERCULES Phase III study, showing that tolebrutinib delayed the time to onset of six-month confirmed disability progression by 31% compared to placebo.
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