Summary
- The European Commission approved Sanofi’s Cenrifki for the treatment of secondary progressive multiple sclerosis, a stage where disability steadily worsens, following a favorable opinion from the European Medicines Agency.
- The U.S. Food and Drug Administration declined Sanofi’s application for the same drug, stating a favorable benefit-risk profile could not be established.
- Sanofi booked a 1.66 billion-euro write-down on tolebrutinib in 2025 after negative results in a late-stage clinical trial for a different type of MS.
- The drug, a BTK inhibitor, was originally acquired through Sanofi’s $3.7 billion purchase of Principia Biopharma in 2020.
Sanofi received European Union approval for Cenrifki, a new treatment for secondary progressive multiple sclerosis, on Tuesday, the company said. The authorization from the European Commission came months after the U.S. Food and Drug Administration rejected the same application, creating a transatlantic regulatory divergence for the French drugmaker.
The EU approval follows a favorable opinion from the European Medicines Agency earlier this year, which Sanofi cited in its announcement. The company said it would make Cenrifki commercially available in Germany this year. The drug, known as tolebrutinib during its development phase, is a BTK inhibitor that blocks a protein involved in the immune system to address the underlying process by which MS disability accumulates.
Sanofi’s new Chief Executive, Belen Garijo, is seeking to accelerate the development of the company’s medicine pipeline, according to the company’s statement. The EU authorization came after the FDA declined Sanofi’s application, saying at the time that a favorable benefit-risk profile could not be established. The company said the EU approval was based on results of a late-stage clinical study, with supporting data from two additional trials for the drug in relapsing multiple sclerosis, the most common form of the disease.
Sanofi booked a 1.66 billion-euro ($1.90 billion) write-down on tolebrutinib alongside its 2025 results, citing a reduced probability of approval in light of negative results in a late-stage clinical trial for a different type of MS. Sanofi acquired full control over the drug as part of its $3.7 billion deal for Principia Biopharma in 2020. Swiss rivals Roche and Novartis are developing their own BTK inhibitors for multiple sclerosis, the company noted.
Separately, Sanofi said it received approval in Japan for its drug Wayrilz to treat immune thrombocytopenia, a rare disease.