Priority Review For MS Pill
FDA Grants Priority Review to Roche for Experimental Multiple Sclerosis Pill Fenebrutinib
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Key Points
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In the two FENhance Phase III trials, fenebrutinib reduced annualized relapse rates by 51.1% and 58.5% versus teriflunomide, respectively. In the FENtrepid PPMS trial, it showed a numerical 12% reduction in disability-progression risk versus Ocrevus; the 95% confidence interval (0.75–1.03) included 1.0.
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The development program faced a partial clinical hold, and Roche reported a case of liver-enzyme elevations meeting the Hy’s law threshold, a signal associated with increased concern about potential serious liver injury.
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Roche Pharma CEO Teresa Graham said Ocrevus has helped more than 525,000 people, but more than a third of people with MS still receive lower-efficacy treatment; she described fenebrutinib as a potential high-efficacy oral option that could give patients more flexibility and choice.
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Other BTK-inhibitor candidates have encountered setbacks in MS: development programs from Merck KGaA and Sanofi were slowed by liver-related side effects and missed goals in large relapsing-MS trials, while Sanofi’s Cenrifki was rejected in the United States in part over safety concerns.
The FDA accepted Roche's application for fenebrutinib, an experimental pill for multiple sclerosis, and granted it priority review BiopharmaDive. If approved, the drug would be the first oral Bruton's tyrosine kinase inhibitor — or BTK inhibitor — authorized for MS. Fenebrutinib showed strong results in testing: it cut relapse rates by 51-59% versus a competing drug in relapsing MS trials, and matched a leading MS treatment on disability progression in primary progressive MS.
Approval isn't guaranteed. The FDA may worry about safety concerns, including liver damage signals and an unusual imbalance in deaths during the trials GuruFocus. Priority review means the FDA has six months to decide. Roche hasn't announced when a final decision will come.
Strong Trial Results Beat Competing Treatments
In two large trials called FENhance, fenebrutinib beat teriflunomide, an older MS drug. In the first trial, fenebrutinib cut annualized relapse rates by 51.1% Yahoo Finance. In the second, it reduced relapses by 58.5%. For primary progressive MS — a more disabling form of the disease — fenebrutinib showed a 12% reduction in disability-progression risk versus Ocrevus, Roche's existing blockbuster MS drug.
Safety Concerns Shadow the Approval Path
Fenebrutinib faced a partial clinical hold during development — a regulatory pause signaling safety worries PMLiVE. One patient showed liver-enzyme elevations that met Hy's law, a medical threshold that flags potential serious liver injury. An imbalance in deaths also occurred during testing, though details remain limited. Other BTK inhibitors for MS have stumbled on similar hurdles: Sanofi's Cenrifki was rejected in the US over safety concerns, and Merck KGaA and Sanofi's programs stalled due to liver side effects.
Roche Pitches Oral Option for Underserved Patients
Roche Pharma CEO Teresa Graham said Ocrevus has helped more than 525,000 people worldwide. Yet more than a third of MS patients still receive lower-efficacy treatments Finance Yahoo. Graham described fenebrutinib as a potential high-efficacy oral option that gives patients more choice and flexibility — avoiding injections or infusions. An approved pill could shift how doctors treat both relapsing and progressive MS.
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