Sanofi today announced that the anticipated US regulatory decision for its investigational drug, tolebrutinib, for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) will be delayed.
The company stated that the ongoing discussions with the U.S. Food and Drug Administration (FDA) indicate the regulatory review process is expected to extend beyond the previously communicated US target action date of December 28, 2025. Sanofi now anticipates receiving further guidance from the FDA by the end of the first quarter of 2026.
Despite the delay, Sanofi reiterated its strong confidence in the therapeutic potential of the drug. “Sanofi strongly believes in the risk-benefit profile of tolebrutinib for the treatment of nrSPMS,” the company stated in its update.
In a related development, Sanofi confirmed it has submitted an expanded access protocol for tolebrutinib in nrSPMS, a measure taken in response to a request from the FDA. This protocol underscores the company’s commitment to ensuring eligible patients can access the investigational therapy while the regulatory review continues.
Targeting Smoldering Neuroinflammation
Tolebrutinib is an investigational, oral, brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor. The drug is specifically designed to target “smoldering neuroinflammation,” a process identified as a key driver of disability progression in multiple sclerosis (MS). By addressing these inflammatory processes, Sanofi aims to mitigate the neurodegeneration and disability accumulation associated with progressive forms of the disease.
Secondary progressive multiple sclerosis (SPMS) typically affects individuals who initially had relapsing MS but have transitioned to a course where disability continuously accumulates, often in the absence of acute relapses. Non-relapsing SPMS (nrSPMS) specifically refers to patients who are no longer experiencing relapses but continue to see their disability worsen.
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Sanofi highlights that addressing disability accumulation remains a significant unmet need for MS patients, given the limited treatment options currently available for progressive forms of the disease. Tolebrutinib represents a key component of Sanofi’s commitment to developing innovative treatments for neuro-inflammatory and neuro-degenerative conditions, including its robust neurology pipeline, which currently features several projects in Phase 3 studies.
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