MHRA Approves Sanofi’s Teplizumab to Delay Onset of Stage III T1D

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The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved teplizumab, a humanized monoclonal antibody from Sanofi that targets the CD3 protein, to delay the onset of symptomatic, Stage III autoimmune type 1 diabetes (T1D) in adults as well as pediatric patients aged eight and older with Stage II T1D (1). With MHRA’s authorization, the UK becomes the first country in Europe to have teplizumab approved for this indication.

T1D can occur at any age, without prior family history, Sanofi said (1). It is a lifelong condition that currently affects approximately 400,000 people in the UK. At Stage III, people may experience symptoms such as increased thirst and weight loss, which usually leads to them being officially diagnosed; this results in a daily regimen of multiple insulin injections or pump use, continuous glucose monitoring, strict dietary management, and risk for acute complications (1).

“Teplizumab essentially trains the immune system to stop attacking the beta cells in the pancreas, allowing the pancreas to produce insulin without interference,” Parth Narendran, professor of Diabetes Medicine, University of Birmingham, and The Queen Elizabeth Hospital Birmingham, said in a Sanofi press release on Aug. 14, 2025 (1). “This can allow eligible patients to live normal lives, delaying the need for insulin injections and the full weight of the disease's daily management by up to three years. It allows people to prepare for disease progression rather than facing an abrupt emergency presentation.”

Teplizumab’s journey

According to Sanofi, teplizumab in 2021 became one of the first investigational medicines to be designated with an Innovation Passport under MHRA’s UK Innovative Licensing and Access Pathway (1). In November 2022, FDA approved teplizumab injection to delay the onset of Stage III T1D in patients eight years of age and older with Stage II preclinical disease (1,2).

Shortly thereafter, the analytics company Clarivate included teplizumab—which at the time was marketed by Provention Bio under the brand name Tzield—in its annual Drugs to Watch report for 2023. A summary of that report appeared in the January 2023 issue of Pharmaceutical Technology® (3).

Then in April 2023, Sanofi completed its acquisition of Provention Bio, which was accomplished by the merger of a wholly owned subsidiary of Sanofi with and into Provention Bio, allowing the latter company to continue as a surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi (4). At the time of the transaction, Sanofi said the addition of teplizumab to its core asset portfolio would help drive a strategic shift for the company toward products with a differentiated profile.

Areas of interest for Sanofi

Sanofi has been turning its strategic emphasis to neurology, highlighted by the May 2025 acquisition of the clinical-stage biotechnology company Vigil Neuroscience, a deal intended to enhance Sanofi’s capabilities in early-stage drug development in this therapeutic area (5).

On July 31, 2025, Sanofi was one of 17 pharmaceutical companies to receive letters from US President Donald Trump that outlined a 60-day window to complete a step-by-step process to lower US prescription drug prices to the lowest price offered among other developed nations, a strategy known as most-favored-nation pricing (6).

And in another US policy decision involving Sanofi, the company was notified on Aug. 5, 2025 that it was among those for whom pre-award solicitations were being canceled or rejected by the US Health and Human Services (HHS)’ Biomedical Advanced Research and Development Authority (BARDA), as part of an HHS wind-down of messenger RNA (mRNA) vaccine development activity under BARDA (7).

While HHS did not specify the exact projects that were being sunsetted, Secretary Robert F. Kennedy Jr. pointed to data showing the reported ineffectiveness of mRNA vaccines against upper respiratory infections such as influenza and COVID-19 (7).

References

1. Sanofi. First Disease-Modifying Type 1 Diabetes Treatment Licensed to Delay the Onset of Symptomatic Stage III Autoimmune Type 1 Diabetes (T1D) in Adult and Pediatric Patients 8 Years of Age and Older with Stage II T1D. Press Release. Aug. 14, 2025.
2. BioPharm International. FDA Approves Injection Designed to Delay Onset of Type 1 Diabetes. BioPharmInternational.com, Nov. 21, 2022.
3. Thomas, F. Getting Personal for Blockbusters in 2023. Pharmaceutical Technology 2023, 47 (1).
4. Sanofi. Sanofi Completes Acquisition of Provention Bio, Inc. Press Release. Apr. 27, 2023.
5. Sanofi. Sanofi to Acquire Vigil Neuroscience, Inc., Adding a New Investigational Medicine to Treat Alzheimer’s Disease to the Neurology Pipeline. Press Release. May 21, 2025.
6. The White House. Fact Sheet: President Donald J. Trump Announces Actions to Get Americans the Best Prices in the World for Prescription Drugs. WhiteHouse.gov, July 31, 2025.
7. HHS. HHS Winds Down mRNA Vaccine Development Under BARDA. Press Release. Aug. 5, 2025.