Drugs

Roche BTK Inhibitor Sees Positive Phase 3 MS Data

Roche says its investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib showed the strongest late-stage results yet reported for the drug class in multiple sclerosis, meeting primary endpoints in two pivotal Phase 3 studies and positioning the oral therapy as a potential competitor — and possible successor — to some of the field’s most effective biologics.

In relapsing MS, the first of two nearly identical studies, FENhance 2, showed that fenebrutinib significantly reduced annualized relapse rates compared with the active comparator teriflunomide over at least 96 weeks, according to the company Full efficacy data were not disclosed, but Roche describes the outcome as “unprecedented” for a BTK inhibitor in MS. A second study, FENhance 1, is expected to read out in the first half of 2026 and will be required before regulatory submissions.

Meanwhile, in primary progressive MS — an area with just one approved therapy — the FENtrepid trial met its primary endpoint, demonstrating that fenebrutinib was non-inferior to Roche’s own Ocrevus (ocrelizumab) in delaying the onset of confirmed disability progression over at least 120 weeks. Roche says the therapy even showed a numerical advantage as early as week 24, a trend that reportedly persisted through the observation period.

Fenebrutinib is described as a non-covalent, reversible BTK inhibitor designed to block inflammatory B-cell activity as well as microglial activation in the central nervous system — targeting both acute relapses and the chronic neurodegeneration thought to drive disability progression.

Safety signals, including liver-related findings, were consistent with earlier Phase II studies, the company said, though additional analyses are underway, Roche says.

If the second study confirms the current results, Roche is expected to move quickly toward global regulatory submissions — potentially positioning fenebrutinib as the first oral therapy to show high efficacy across both MS types.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome