Overview
- Roche said Wednesday it submitted fenebrutinib to regulators worldwide after late-stage studies hit their main goals.
- New relapsing multiple sclerosis data showed the pill kept patients relapse-free for more than twice as long as Sanofi’s teriflunomide.
- Trials reported seven deaths during treatment, equal to 0.9%, plus one death after the studies, compared with one death, or 0.1%, in teriflunomide’s trials.
- Roche said investigators linked two deaths to infections and reported no liver-related deaths, with severe liver problems on par with the comparator.
- Jefferies cautioned in February that approval and peak sales near 3 billion Swiss francs may be optimistic, while Roche says the benefit–risk looks favorable and expects the drug to sit alongside its IV therapy Ocrevus.