Sanofi Multiple Sclerosis Drug Gets EU Approval — Update

By Adria Calatayud

Sanofi said it received approval in the European Union for a new medicine for multiple sclerosis, months after it was turned down by U.S. drug regulators.

The EU approval comes as Sanofi's new Chief Executive Belen Garijo is seeking to turn around the French drugmaker's research engine, in a bid to accelerate the development of its medicine pipeline.

Sanofi said Tuesday that the drug, Cenrifki, was approved by the European Commission--the bloc's executive arm--for the treatment of secondary progressive MS--a stage of the disease at which patients' disability steadily worsens--without relapses in the previous two years.

The company said it would make Cenrifki--which was known as tolebrutinib during its development phase--commercially available in Germany this year.

Shares in Sanofi were up 1.7%.

The EU authorization came after the European Medicines Agency earlier this year issued a favorable opinion, in contrast with the U.S. Food and Drug Administration's decision to decline Sanofi's application. The FDA said at the time a favorable benefit-risk profile couldn't be established.

Tolebrutinib is a so-called BTK inhibitor that blocks a protein involved in the immune system to address the underlying process by which MS disability accumulates. Sanofi's Swiss rivals Roche and Novartis are developing their drugs in the same class for MS.

Sanofi acquired full control over the drug as part of its $3.7 billion deal for Principia Biopharma in 2020.

The company 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 and its interactions with U.S. and EU drug regulators.

Sanofi 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.

The company separately said Tuesday that it received approval in Japan for its drug Wayrilz to immune thrombocytopenia, a rare disease.

Write to Adria Calatayud at adria.calatayud@wsj.com

(END) Dow Jones Newswires

June 23, 2026 07:31 ET (11:31 GMT)