BioCentury
ARTICLE | Product Development

The evolving BTK story in multiple sclerosis: Clinical Report

As Sanofi awaits an FDA decision in secondary progressive MS, its miss in primary progressive disease sets up Roche to maintain market leadership

December 16, 2025 10:22 PM UTC

Among notable clinical readouts this week was a Phase III miss by Sanofi that further cements Roche’s dominance in multiple sclerosis.

After producing a statistically significant slowing of progression in a Phase III study in secondary progressive MS, Sanofi (Euronext:SAN; NASDAQ:SNY) announced that its BTK inhibitor, tolebrutinib, failed to replicate the effect in patients with primary progressive disease, in which symptoms worsen from the outset without a relapsing phase...