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Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation independent of relapse activity in adults.
The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.
The FDA filing is supported by data from three late-stage studies — one (HERCULES) in nrSPMS and two (GEMINI 1 and 2) in relapsing MS (RMS). Data from these studies showed that patients treated with tolebrutinib delayed the time to onset of six-month confirmed disability progression when compared to placebo. A similar regulatory filing for the drug is currently under review by the EMA, which is also supported by data from these studies.
Per Sanofi, the above results make tolebrutinib the first and the only brain-penetrant BTK inhibitor to treat both the above MS indications. If approved, tolebrutinib will also be the first therapy designed to target smoldering neuroinflammation, a key driver of disability accumulation in MS. By showing a clinically meaningful benefit in disability accumulation, tolebrutinib holds the potential to address a significant unmet need in MS.
MS is a chronic neurodegenerative disease that causes disability accumulation over time, which is not properly addressed by the currently available therapies that are designed to primarily address peripheral inflammation. There are no approved therapies to treat nrSPMS at present.
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Year to date, Sanofi’s shares have risen 16% compared with the industry’s 6% growth.
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More on SNY's Tolebrutinib
Besides nrSPMS and RMS, Sanofi is also evaluating the drug in the phase III PERSEUS study in patients with primary progressive MS. Data from this study is expected to be released in the second half of 2025.
Tolebrutinib was added to Sanofi’s portfolio with the acquisition of Principia in 2020.
In 2022, the FDA placed a partial clinical hold on Sanofi’s phase III studies on tolebrutinib in MS and myasthenia gravis (MG) indications after the regulatory agency identified cases of drug-induced liver injury in some study participants who were administered the drug.
The MG studies on tolebrutinib were eventually discontinued in 2022 after careful evaluation of the emerging competitive treatment landscape.
SNY’s Zacks Ranks
Sanofi currently carries a Zacks Rank #3 (Hold).