Roche's multiple sclerosis drug fenebrutinib meets goal in late-stage trial
Roche's experimental multiple sclerosis drug fenebrutinib has met its main goal in a late-stage trial for primary progressive multiple sclerosis (PPMS). The Phase III study showed a 12% reduction in the risk of worsening disability compared to Roche's Ocrevus, the only approved treatment for PPMS. The drug is the first in over a decade to demonstrate a reduction in disability progression in PPMS. Roche plans to seek regulatory approval after additional Phase III data from a relapsing MS trial, expected in early 2026.
BERLIN, Feb 7 (Reuters) - Swiss pharmaceutical company Roche (ROG.S) said on Saturday its experimental multiple sclerosis drug fenebrutinib met the main goal in a late-stage trial in patients with primary progressive multiple sclerosis, a rare form of the disease with few treatment options.
In the Phase III study, fenebrutinib cut the risk of worsening disability by 12% compared with Roche’s Ocrevus, the only approved therapy for PPMS, the Swiss drugmaker said.
Separation of the treatment curves was seen after 24 weeks, and additional analyses suggested potential benefits in upper-limb function.
PPMS is the least common form of multiple sclerosis and is marked by a steady progression of disability from the outset.
Roche said fenebrutinib was the first experimental therapy in more than a decade to show a reduction in disability progression in a PPMS study.
The company said it plans to submit the drug for regulatory approval once additional Phase III data from a relapsing MS trial are available, which it expects in the first half of 2026.
