By Joshua Kirby
Roche said it would submit trial data for its multiple sclerosis treatment fenebrutinib to regulators, despite reporting deaths of patients taking the drug during the trial.
Phase-3 studies of fenebrutinib--an inhibitor for sufferers of relapsing MS--met primary endpoints of reducing relapse rates among patients in the trial, the Swiss drugmaker said Wednesday. The studies showed fenebrutinib cut relapses by half compared with a rival treatment, Roche said.
"By more than doubling the time without relapses compared to [the rival treatment], fenebrutinib may offer patients years of relapse-free living, thereby preserving both daily independence and long-term function," said Levi Garraway, Roche's chief medical officer. The data will now be submitted to regulatory authorities, Roche said.
Nevertheless, an imbalance of deaths was observed during the trial, Roche said. Seven deaths were observed in the fenebrutinib arm, compared with one in the arm receiving the similar drug.
All but two of the deaths in the former arm were assessed by investigators as being unrelated to the study drug, a spokesperson for Roche said. The exceptions were two infection-related deaths, she said.
"Patient safety is Roche's highest priority," the spokesperson said. "Further analyses are ongoing to better understand these findings."
Write to Joshua Kirby at joshua.kirby@wsj.com; @joshualeokirby
(END) Dow Jones Newswires
April 22, 2026 10:00 ET (14:00 GMT)
Copyright (c) 2026 Dow Jones & Company, Inc.
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