Sanofi’s Cenrifki Wins EU Approval for Non-Relapsing Secondary Progressive MS | iPharmaCenter

Sanofi’s Cenrifki has received European Commission approval for adults with secondary progressive multiple sclerosis without relapses in the past two years, adding a new treatment option for a patient group with limited choices.

The approval is intended for people whose disease continues to progress even after relapses have subsided, which makes disability control a central treatment goal.

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The decision is supported by phase 3 data from HERCULES, a randomized, double-blind study that evaluated tolebrutinib in people with non-relapsing secondary progressive MS.

In this trial, 1,131 participants were assigned in a 2:1 ratio to receive either tolebrutinib 60 mg once daily or placebo, with treatment lasting up to about 48 months.

• The main endpoint was six-month confirmed disability progression, while secondary measures included three-month disability progression, MRI lesion activity, disability improvement, and functional tests such as the 9-hole peg test and timed 25-foot walk test.

HERCULES showed that tolebrutinib delayed disability progression compared with placebo, supporting its role as a therapy designed to slow the worsening of MS rather than simply manage relapses.

The broader clinical package also included GEMINI 1 and GEMINI 2, two phase 3 randomized, double-blind, double-dummy studies in relapsing MS that enrolled 1,873 participants in total. These trials compared daily tolebrutinib with teriflunomide and assessed annualized relapse rate, disability worsening, MRI activity, and safety outcomes.

Cenrifki is an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor designed to target smoldering neuroinflammation, which is considered a driver of disability accumulation in MS. Sanofi says the safety profile has remained consistent across the clinical program, strengthening the evidence base behind the approval.