European drug regulators have issued a positive review for Sanofi’s experimental multiple sclerosis (MS) treatment. This move comes after the U.S. Food and Drug Administration (FDA) rejected the drug earlier this year, positioning the therapy to potentially receive its first marketing authorization in the coming months.
Specifically, the European Medicines Agency (EMA) has recommended the clearance of tolebrutinib for individuals with non-relapsing “secondary progressive” multiple sclerosis. If officially approved, the drug will be sold under the brand name Cenrifki. The therapy was the centerpiece of Sanofi’s $3.7 billion acquisition of Principia Biopharma in 2020.
Tolebrutinib is part of a new class of drugs known as BTK inhibitors. Unlike their predecessors, these newer blockers are capable of crossing the blood-brain barrier, offering the potential to delay disability progression—one of the most significant unmet needs in MS care. While the EMA acknowledged potential liver-related side effects, it emphasized the therapy’s meaningful benefits in slowing disease progression. This contrasts with the FDA’s earlier rejection, which cited risks of severe or fatal drug-induced liver injury, a decision Sanofi argued represented a “significant change in direction” from previous regulatory feedback.