Joanna Sadowska, Biopharma Account Specialist at Nanolive SA, shared a post on LinkedIn:
“Breaking News – For the first time in 10+ years, a new therapy slows progression in primary progressive multiple sclerosis
Roche shows 12% reduction in disability progression in PPMS in Phase 3 of its investigational BTK inhibitor fenebrutinib.
This is the first therapy in over 10+ to do so and can potentially start a new era after OCERVUS.
Fenebrutinib is an oral, brain-penetrant, reversible BTK inhibitor designed to:
- Target B cells (relapsing biology)
- Target microglia inside the CNS (progressive biology)
Unlike many covalent BTK inhibitors, it is non-covalent and highly selective, potentially limiting off-target effects.
The results from Phase 3 showed:
- 12% reduction in risk of confirmed disability progression vs OCREVUS
- 26% reduction in upper limb worsening (9HPT component)
- Comparable overall safety profile
Regulatory submission is planned following the second RMS Phase III readout in 1H 2026. If approved, fenebrutinib could become the first oral therapy for PPMS and the first new mechanism in progressive MS in over a decade.
Hi! I am Joanna, and my friends call me Dr Jojo
I help startups and entrepreneurs market their value and innovation.
Share this if you find it interesting
Follow for insights you won’t want to miss
DM me to increase your visibility, grow your business, and generate leads.”
Other articles featuring Roche on OncoDaily.