Sanofi: Positive Publication of Tolebrutinib Data in NEJM

Sanofi announced the publication in the New England Journal of Medicine of the results of the phase III HERCULES study of tolebrutinib. This drug delays the progression of disability in patients with non-relapsing secondary progressive multiple sclerosis (SPMS), for whom no current options exist. By targeting inflammation behind the blood-brain barrier, tolebrutinib offers a novel approach, distinct from treatments acting on peripheral lymphocytes.

The results of the GEMINI 1 and 2 studies, also published, did not show superiority of tolebrutinib over teriflunomide in reducing the relapse rate. However, a pooled analysis demonstrated that tolebrutinib slowed disability progression by 29% compared to teriflunomide.

Currently under priority review by the FDA, a decision is expected by September 2025, with a submission also underway in Europe.