Sanofi Secures European Approval for Disease-Modifying Type 1 Diabetes Therapy

(IN BRIEF) The European Commission has approved Sanofi’s Teizeild as the first disease-modifying therapy in the EU to delay the onset of stage 3 type 1 diabetes in adults and children with stage 2 T1D. Supported by TN-10 phase 2 study results, the approval marks a significant shift toward early intervention in autoimmune type 1 diabetes by slowing disease progression and protecting beta-cell function.

(PRESS RELEASE) PARIS, 12-Jan-2026 — /EuropaWire/ — Sanofi has received European Commission approval for Teizeild (teplizumab) to delay the progression to stage 3 type 1 diabetes (T1D) in adults and children aged eight years and older who are diagnosed with stage 2 T1D. The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and represents a major regulatory milestone, as Teizeild becomes the first disease-modifying therapy for type 1 diabetes approved in the European Union.

The approval is based on results from the TN-10 phase 2 clinical study, which demonstrated that Teizeild significantly delayed the onset of stage 3 T1D compared with placebo. In the study, patients receiving Teizeild experienced a median delay of two years before progressing to clinical diabetes, highlighting the therapy’s potential to alter the natural course of this autoimmune disease by preserving pancreatic beta-cell function.

Sanofi emphasized that this approval marks a shift in how type 1 diabetes can be addressed, moving beyond symptom management toward targeting the underlying immune process that drives disease progression. According to the company, Teizeild offers patients and families an opportunity to postpone the need for lifelong insulin therapy and reduce the burden associated with the clinical onset of T1D.

Clinical data from the TN-10 study showed that nearly twice as many patients treated with Teizeild remained in stage 2 T1D at the end of the trial compared with those receiving placebo. The safety profile observed was consistent with previous studies, with the most common adverse events including transient lymphopenia and skin-related reactions such as rash.

Teizeild is already approved in several other markets, including the United States, the United Kingdom, China, Canada, Israel, Saudi Arabia, the United Arab Emirates and Kuwait, for the same indication. Following the EU approval, Sanofi confirmed that it will not pursue an additional application for use of Teizeild in recently diagnosed stage 3 T1D at this time, while further regulatory reviews in other regions remain ongoing.

Type 1 diabetes is a progressive autoimmune condition characterized by the immune-mediated destruction of insulin-producing beta cells. By intervening at stage 2, when the disease is still presymptomatic but blood glucose regulation has begun to deteriorate, Teizeild aims to delay progression to clinical diabetes and preserve remaining beta-cell function for as long as possible.

About TN-10
The pivotal TN-10 phase 2 study was a randomized, placebo-controlled, double-blind study which evaluated Teizeild for the delay of stage 3 T1D in adults and children aged eight years and older diagnosed with stage 2 T1D (presence of at least two T1D-related autoantibodies and dysglycemia) who are relatives of people living with autoimmune T1D. Seventy-six participants aged eight to 45 were enrolled (Teizeild n=44, placebo n=32). They were randomized to receive a single 14-day course of either Teizeild or placebo.

The primary endpoint was the elapsed time from randomization to the clinical diagnosis of autoimmune stage 3 T1D (progression from stage 2 T1D to stage 3 T1D). Key secondary end points included safety and tolerability.

Results demonstrated that the median time to the diagnosis of stage 3 T1D was 48.4 months in the Teizeild group and 24.4 months in the placebo group. The disease was diagnosed in 19 (43%) of the participants who received Teizeild and in 23 (72%) of those who received placebo. The hazard ratio for the diagnosis of type 1 diabetes (Teizeild vs. placebo) was 0.41 (95% CI: 0.22 to 0.78; p=0.006 by adjusted Cox proportional-hazards model). There were expected adverse events of rash and transient lymphopenia.

About Teizeild
Teizeild (teplizumab) is a CD3-directed monoclonal antibody. Teizeild is the first and only disease modifying therapy in autoimmune T1D; it was approved in the US in November 2022 to delay the onset of stage 3 type 1 diabetes in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. Other regulatory reviews are ongoing.

About autoimmune T1D
T1D is a progressive autoimmune disease where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system.

There are four stages to the progression of T1D:

In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more T1D-related autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycemia). At this stage, T1D is presymptomatic.
In stage 2 (also presymptomatic), in addition to the presence of 2 or more T1D-related autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells / beta cell function.
Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision, and generalized fatigue. Management of stage 3 T1D requires daily and burdensome insulin replacement therapy.
Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications, where little to no beta-cell function remains (it’s been estimated that beta-cell mass is reduced by up to 95%). At this point, the T1D-related autoantibodies might not be present anymore in the blood, as most beta-cells have been rendered useless by the autoimmune attack.

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.

Sanofi forward-looking statements

This press release contains forward-looking statements as defined in 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. 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 and uncertainties 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, 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 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 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, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Sanofi Secures European Approval for Disease-Modifying Type 1 Diabetes Therapy

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