Europe’s drug advisory committee recommended approval of Sanofi’s (SNY) Cenrifki for non-relapsing secondary progressive MS on April 24, a milestone that partially offsets a costly U.S. setback and signals renewed pipeline durability for the French pharma giant.
For long-horizon investors tracking Sanofi’s revenue mix, the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) matters because it opens a commercial path for a drug the company acquired for $3.7 billion – one that had yet to generate any approved-market returns. 1
Key Takeaways
- CHMP backed Cenrifki for SPMS without relapses in past two years.
- FDA rejected the same drug in January over liver-injury safety concerns.
- Sanofi recorded a ~€1.7 billion impairment charge tied to tolebrutinib setbacks.
Pipeline Context & Market Backdrop
Sanofi’s tolebrutinib belongs to a newer generation of brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitors targeting smoldering neuroinflammation – a mechanism distinct from the adaptive-immune therapies that dominate the current MS market. 2 Rival BTK programs have faced their own turbulence: Merck KGaA’s evobrutinib failed in late-stage MS trials, and Roche’s fenebrutinib faces lingering approval questions for relapsing MS, leaving tolebrutinib as the furthest advanced in the progressive-MS segment. 2
A final European Commission decision on Cenrifki is expected within months, according to Sanofi. 1 The drug already holds provisional approval in the United Arab Emirates for the same indication, with additional regulatory reviews ongoing globally. 3
What the Data Show
The CHMP opinion rests primarily on the Phase 3 HERCULES study, in which tolebrutinib delayed the onset of six-month confirmed disability progression by 31% compared with placebo. 3 Supporting data from the GEMINI 1 and GEMINI 2 studies in relapsing MS, published in The New England Journal of Medicine, provided additional context for the safety and efficacy profile. 1
The EMA also noted a 38% reduction in new and/or enlarging T2-hyperintense brain lesions per year versus placebo. 3 On the safety side, the agency flagged elevated liver enzymes as an identified risk; Sanofi said strict monitoring protocols are required to mitigate drug-induced liver injury. 1
The U.S. Setback and Impairment Charge
The FDA rejected tolebrutinib in January 2026, citing the liver-injury risk and questioning the drug’s net clinical benefit. 2 Sanofi said the rejection represented a
“significant and meaningful change in direction”
from earlier agency feedback – language that underscored the degree to which the company had not anticipated the outcome. 2
Combined with the failure of the Phase 3 PERSEUS trial in primary progressive MS – which caused Sanofi to abandon PPMS filing plans entirely – the company recorded an impairment charge of nearly €1.7 billion ($2 billion) tied to the tolebrutinib program. 3 That charge frames the EU approval as a partial, but meaningful, recovery of value from the original Principia Biopharma acquisition. 2
Outlook for Revenue Mix
Non-relapsing SPMS is a condition characterised by continuous disability accumulation – including fatigue, cognitive impairment and loss of mobility – without the episodic relapses that current approved therapies typically address. 1 Sanofi described addressing disability progression as “one of the most significant unmet needs in MS care,” and the absence of competing approved therapies in the non-relapsing SPMS segment gives Cenrifki potential pricing leverage in Europe. 1
Sanofi said it continues to pursue regulatory clearances in other markets, though no timelines were specified. 1 Separately, the company’s broader BTK portfolio already includes Wayrilz, approved for an immune condition, indicating an expanding autoimmune franchise that could support long-term revenue diversification. 2
Conclusion
The CHMP positive opinion does not erase the $3.7 billion cost of the Principia acquisition or the near-$2 billion impairment charge, but it marks tolebrutinib’s first pathway to a major regulated market and demonstrates that the HERCULES efficacy data can satisfy at least one major regulatory body. 23 Investors with long time horizons will be watching the final European Commission decision – expected in the coming months – as the first concrete revenue signal for a program that has so far only generated losses. 1
Not investment advice. For informational purposes only.
References
1(Apr 24, 2026). “Press Release: Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses”. Sanofi. Retrieved June 23, 2026.
2Alvarado, Delilah (Apr 24, 2026). “Sanofi MS drug rejected in US gets an endorsement in Europe”. BioPharma Dive. Retrieved June 23, 2026.
3Dennis, Matthew (Apr 24, 2026). “Sanofi gets some good news for BTK inhibitor tolebrutinib, as EU body backs approval”. FirstWord Pharma. Retrieved June 23, 2026.