Roche reported that fenebrutinib, its experimental oral drug, has achieved primary endpoints in two distinct, pivotal Phase III trials for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS). The encouraging outcomes suggest that fenebrutinib may be a first-of-its-kind, highly effective oral treatment for the two most prevalent types of the illness.
The medication was assessed in patients with relapsing multiple sclerosis in the first study, FENhance 2. The findings demonstrated that, over a 96-week period, fenebrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK), significantly decreased the annualised relapse rate (ARR) in comparison to teriflunomide, the current standard-of-care treatment.
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The FENtrepid study for primary progressive multiple sclerosis also achieved its primary endpoint, which is a second significant development. In terms of slowing the progression of disability over a period of 120 weeks, the study showed that fenebrutinib was not inferior to OCREVUS (ocrelizumab), the only approved treatment for PPMS. According to Roche, a numerical advantage of fenebrutinib over OCREVUS was seen as early as week 24 and persisted for the duration of the trial.
These results are important because fenebrutinib may be the first and only BTK inhibitor to be effective in treating both progressive and relapsing forms of MS.
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Future Outlook
Data from a second RMS study with a similar design (FENhance 1) is anticipated in the first half of 2026, according to Roche. The business intends to take into account all of the data before submitting it to regulatory bodies. The good news was welcomed because it might give those with both major forms of MS new hope for a convenient oral therapy.
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