Press Release : Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis

Core Insights - Sanofi's regulatory submission for tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS) is expected to face delays, with further guidance from the FDA anticipated by the end of Q1 2026 [1][2] - The company has submitted an expanded access protocol for tolebrutinib, demonstrating its commitment to providing access to this investigational therapy for eligible patients [2] - Tolebrutinib is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor designed to target neuroinflammation, a key factor in disability progression in multiple sclerosis [5][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative treatments, particularly in neurology and immunoscience [7] - The company is committed to addressing significant unmet needs in multiple sclerosis and other neuro-inflammatory and neuro-degenerative conditions [6][7] - Sanofi's neurology pipeline includes several projects in phase 3 studies across various diseases, indicating a robust commitment to advancing treatment options [6]