Sanofi Multiple Sclerosis Drug Gets EU Approval

By Adria Calatayud

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

The French drugmaker said Tuesday that the MS drug, Cenrifki, was approved by the European Commission--the bloc's executive arm--for the treatment of secondary progressive multiple sclerosis without relapses, a stage of the disease at which patients' disability steadily worsens.

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

The EU approval followed a positive opinion by the European Medicines Agency's committee for medicinal products for human use earlier this year and 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 European authorization comes after the U.S. Food and Drug Administration in December last year declined Sanofi's application for the drug, saying a favorable benefit-risk profile couldn't be established.

Sanofi 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 01:43 ET (05:43 GMT)