NEJM: Tolbrutinib slows disability progression in relapsing-remitting MS

In a large NEJM study, the oral BTK inhibitor tolebrutinib showed a reduction in disability accumulation in patients with relapsing-remitting MS without relapses. This is the first time that there is hope for a targeted effect on the PIRA component (progression independent of relapses).

In participants with non-relapsing secondary progressive multiple sclerosis, the risk of disability progression was lower among those receiving tolebrutinib treatment than among those receiving placebo.

FDA extends tolebrutinib review period to December 28, 2025

The regulator recognized that the additional analyses were a “significant amendment” to the NDA and moved the PDUFA date. The company says it is targeting indications for non-relapsing SP-MS and “slowing disability progression regardless of relapses.” In practice, this means waiting for a decision, but there are already positive clinical signals.

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