Roche reports up to 30% shrinkage of chronic MS lesions with fenebrutinib, eyes FDA approval

Roche has filed for FDA approval of its BTK inhibitor fenebrutinib for both relapsing and primary progressive multiple sclerosis, after the agency accepted the submission.

At the MSToronto2026 meeting the company presented phase 3 data showing up to a 30% reduction in the volume of slowly expanding lesions, a type of chronic active lesion linked to disability progression.

The trial also demonstrated a 62% drop in the accumulation of paramagnetic rim lesions in relapsing MS, which Roche described as the first prospective evidence of a drug affecting chronic inflammation in the brain.

Analysts view these results as a potential breakthrough in addressing disability progression, a key unmet need in the MS therapeutic landscape, and anticipate a product launch next year if the FDA grants approval.