EU Drug Panel Backs Sanofi’s Cenrifki for Non‑Relapsing SPMS

The move sets up a final EU ruling that may give people with progressive MS a needed way to slow disability.

Overview

Cenrifki, an oral tolebrutinib tablet, won a positive opinion from the EMA’s CHMP recommending EU approval for adults with secondary progressive MS without relapses in the past two years.
The committee’s view rests on the HERCULES phase 3 study in non‑relapsing SPMS with supporting evidence from the GEMINI 1 and 2 trials in relapsing MS.
Regulators report a 31% lower risk of six‑month confirmed disability progression versus placebo along with a 38% drop in new or enlarging T2 MRI lesions.
Safety reviews identify drug‑induced liver injury as the main risk, with liver checks highlighted as important to manage enzyme rises seen in the program.
Cenrifki now heads to the European Commission for a final decision in the coming months, while other regulatory reviews are underway worldwide.