Tags: multiple sclerosis, EU approval, SPMS, BTK inhibitor, regulatory

Sanofi gets an EU win in SPMS while the US path stays unresolved

By FieldPulse Editorial · June 23, 2026

Sanofi secured EU approval for Cenrifki in non-relapsing SPMS, but the story still requires careful separation between European momentum and the unresolved US path.

Sanofi has a real regulatory win to point to in multiple sclerosis, even if the US picture remains unsettled.

PharmaTimes reports that the European Commission approved Cenrifki, also known as tolebrutinib, for adults with secondary progressive multiple sclerosis without relapses in the past two years.

The article says the decision was based on the phase 3 HERCULES study in non-relapsing SPMS, with support from the GEMINI 1 and 2 studies in relapsing disease.

Sanofi said the drug significantly delayed disability progression in the HERCULES trial.

PharmaTimes also notes that the company plans to make Cenrifki commercially available in Germany later in 2026.

For field teams, the useful angle is straightforward.

This is an EU approval, not a US approval, and that distinction matters.

The drug previously ran into problems with the FDA, so any discussion of momentum has to stay geographically precise.

Sanofi teams can still point to the approval as validation that regulators saw value in the nrSPMS data package, while competitors should note the differentiation claim around disability progression in a hard-to-treat population.

The other point worth keeping in view is safety.

PharmaTimes says significant liver enzyme elevations were observed and that liver injury is an identified risk, with strict monitoring requirements emphasized.

That means any future positioning conversation is likely to involve both the differentiation story and the monitoring burden.