BIIB-091

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis

5 months ago

• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). • The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo. • Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression. • Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis

Drug Development Updates