{"id":43111,"date":"2026-06-29T08:19:25","date_gmt":"2026-06-29T08:19:25","guid":{"rendered":"https:\/\/www.europesays.com\/france\/43111\/"},"modified":"2026-06-29T08:19:25","modified_gmt":"2026-06-29T08:19:25","slug":"press-release-sanofis-cenrifki-tolebrutinib-approved-in-the-eu-as-the-first-disability-targeting-medicine-for-secondary-progressive-multiple-sclerosis-without-relapses-3","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/france\/43111\/","title":{"rendered":"Press Release: Sanofi\u2019s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses"},"content":{"rendered":"

\"Sanofi<\/a> Sanofi Winthrop Industrie <\/p>\n

Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses <\/p>\n

Cenrifki represents a significant advancement for people living with SPMS by targeting disability progression <\/p>\n

Approval based on the HERCULES phase 3 study in nrSPMS with supporting data from the GEMINI 1 and 2 phase 3 studies in RMS <\/p>\n

Paris, June 23, 2026. The European Commission has approved Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. This follows the positive opinion<\/a> by the European Medicines Agency’s Committee for Medicinal Products for Human Use. <\/p>\n

The approval is based on results from the HERCULES phase 3 study (clinical study identifier: NCT04411641<\/a>) in non-relapsing SPMS (nrSPMS), with supporting data from the GEMINI 1 (clinical study identifier: NCT04410978<\/a>) and GEMINI 2 (clinical study identifier: NCT04410991<\/a>) phase 3 studies in relapsing multiple sclerosis (RMS). The HERCULES study demonstrated that Cenrifki significantly delayed the onset of disability progression in nrSPMS. <\/p>\n

The safety profile of Cenrifki has been consistent across the clinical program. The most common adverse events were COVID-19 and upper respiratory tract infections. Significant liver enzyme elevations were also observed. Drug-induced liver injury (DILI) is an identified safety risk of Cenrifki. Strict adherence to liver monitoring requirements, and prompt management of liver enzyme elevations, are important to mitigate DILI risk. <\/p>\n

Sanofi will make Cenrifki commercially available in Germany this year in close collaboration between local medical teams, treating MS specialists and their patients, all supported by the required Risk Management Program and robust Patient Support Program. This reflects Sanofi’s commitment to a careful approach to introducing this innovative, first-in-class medicine for people living with SPMS without relapses. <\/p>\n

About\u00a0secondary progressive multiple sclerosis\u00a0
SPMS is a debilitating stage of MS where patients experience continuous accumulation of disability, including fatigue, cognitive impairment, mobility difficulties, and loss of independence \u2013 often without available treatment options. Across major European economies, the yearly cost of MS-related disability surpasses the average annual income per person. As disability accumulates, many are forced to reduce working hours or leave the workforce entirely \u2014 while up to 82% of those living with severe MS rely on informal caregiving, extending the strain far beyond the individual. Addressing disability progression remains one of the most significant unmet needs in MS care. <\/p>\n

About HERCULES
HERCULES (clinical study identifier:\u00a0NCT04411641<\/a>) was a double-blind, randomized phase 3 clinical study evaluating the efficacy and safety of tolebrutinib in patients with nrSPMS. At baseline, nrSPMS was defined as having a SPMS diagnosis with an expanded disability status scale (EDSS) between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months. Participants were randomized (2:1) to receive either an oral daily dose of tolebrutinib or matching placebo for up to approximately 48 months. <\/p>\n

The primary endpoint was six-month confirmed disability progression (CDP) defined as the increase of \u22651.0 point from the baseline EDSS score when the baseline score is \u22645.0, or the increase of \u22650.5 point when the baseline EDSS score was >5.0. Secondary endpoints included time to onset of three-month CDP as assessed by EDSS score, total number of new or enlarging T2 hyperintense lesions as detected by MRI, time to onset of confirmed disability improvement, 3-month change in 9-hole peg test and timed 25-foot walk test, as well as the safety and tolerability of tolebrutinib. <\/p>\n

About GEMINI 1 and 2
GEMINI 1 (clinical study identifier:\u00a0NCT04410978<\/a>) and GEMINI 2 (clinical study identifier: NCT04410991<\/a>) were double-blind, randomized phase 3 clinical studies evaluating the efficacy and safety of tolebrutinib compared to teriflunomide, an oral disease-modifying medicine, in patients with RMS. Participants were randomized in both studies (1:1) to receive either tolebrutinib and placebo daily or 14 mg teriflunomide and placebo. <\/p>\n

The primary endpoint for both studies was the annualized relapse rate for up to approximately 36 months defined as the number of confirmed adjudicated protocol defined relapses. Secondary endpoints included time to onset of confirmed disease worsening, confirmed over at least six months, defined as an increase of \u22651.5 points from the baseline EDSS score when the baseline score is 0, an increase of \u22651.0 point from the baseline EDSS score when the baseline score is 0.5 to \u22645.5 or an increase of \u22650.5 point from the baseline EDSS score when the baseline score was >5.5 in addition to the total number of new and\/or enlarging T2 hyperintense lesions as detected by MRI from baseline through the end of study, the total number of Gd-enhancing T1 hyperintense lesions as detected by MRI from baseline through the end of study, and the safety and tolerability of tolebrutinib. <\/p>\n

About\u00a0Cenrifki\u00a0
Cenrifki\u00a0(tolebrutinib)\u00a0is an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in MS. This unique mechanism of action addresses the underlying biology of progressive MS by targeting the inflammatory processes that contribute to disability accumulation. Cenrifki is the first disease-targeting therapy designed to address the underlying process of MS disability accumulation approved in the EU for adults with SPMS without relapses in the last two years. <\/p>\n

Cenrifki is administered once daily with a meal, and treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis. <\/p>\n

Cenrifki is also approved in Australia for the treatment of nrSPMS and to slow disability accumulation in the absence of relapse activity with SPMS and in the United Arab Emirates for the treatment of SPMS without relapses in the last two years. <\/p>\n

Cenrifki\u00a0represents\u00a0Sanofi’s commitment to developing innovative treatments that address the underlying causes of neurological diseases and potentially transform the treatment landscape. Standing at the intersection of neurology and\u00a0immunoscience, Sanofi is focused on improving the lives of those living with serious neuro-inflammatory and neuro-degenerative conditions including MS, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, age-related macular degeneration, and other neurological diseases. The neurology pipeline currently has several projects in phase 3 studies across various diseases.\u00a0 <\/p>\n

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY <\/p>\n

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com<\/a>
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com<\/a>
L\u00e9o Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com<\/a>
Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com<\/a>
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com<\/a>
L\u00e9a Ubaldi\u00a0| +33 6 30 19 66 46 |\u00a0lea.ubaldi@sanofi.com<\/a>
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com<\/a>
Laura Romby| +33 6 74 16 74 29 | laura.romby@sanofi.com<\/a> <\/p>\n

Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com<\/a>
Aliz\u00e9 Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com<\/a>
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com<\/a>
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com<\/a>
Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com<\/a>
Thibaud Ch\u00e2telet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com<\/a>
Yun Li\u00a0| +33 6 84 00 90 72 |\u00a0yun.li3@sanofi.com<\/a> <\/p>\n

Sanofi Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” “attempt,” “target,” “project,” “strategy,” “strive,” “desire,” “predict,” “forecast,” “ambition,” “guideline,” “seek,” “should,” “will,” “goal,” or the negative of these and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues; competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. <\/p>\n

All trademarks mentioned in this press release are the property of the Sanofi group. <\/p>\n

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