Global pharma giant Sanofi has announced that the US regulatory review of its investigational therapy tolebrutinib for non-relapsing secondary progressive multiple sclerosis (nrSPMS) is expected to extend beyond the previously communicated target action date of December 28, 2025.
The company now anticipates further guidance from the FDA by the end of the first quarter of 2026.
In response to an FDA request, Sanofi has submitted an expanded access protocol for tolebrutinib in nrSPMS, highlighting the company’s dedication to providing eligible patients with access to the therapy. “Sanofi strongly believes in the risk-benefit profile of tolebrutinib for the treatment of nrSPMS,” the company said.
Multiple sclerosis (MS) is a progressive neurological disorder marked by disability accumulation and shifts in disease biology over time, which affect clinical presentation and treatment response.
Tolebrutinib, as per the company, is an investigational, oral, brain-penetrant Bruton’s tyrosine kinase inhibitor designed to target smoldering neuroinflammation—a key driver of disability progression in MS. The therapy aims to address the underlying pathology of progressive MS by reducing the inflammatory processes that contribute to neurodegeneration.
“Tolebrutinib represents Sanofi’s commitment to developing innovative treatments that address the underlying causes of neurological diseases and potentially transform the treatment landscape,” the company said.
Sanofi emphasized its broader neurology focus, spanning serious neuro-inflammatory and neurodegenerative conditions including MS, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, and age-related macular degeneration. Its neurology pipeline includes several projects currently in phase 3 studies across multiple diseases.
