The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Sanofi's teplizumab as the country’s first immunotherapy for type 1 diabetes (T1D), specifically for patients aged 8 and older with stage 2 T1D, to delay disease progression to stage 3.

Teplizumab was previously approved in the US in 2022 after clinical trials showed it could delay the onset of symptomatic T1D by an average of three years in high-risk, early-stage individuals.

Sanofi’s teplizumab received FDA approval in November 2022 and was designated with an Innovation Passport by MHRA in 2021, highlighting its potential as a significant advancement in diabetes treatment.

The drug is administered via daily intravenous infusions over 14 days, with common side effects including rash, leukopenia, increased infection risk, and headache, and the MHRA will monitor safety closely.

Clinical trials suggest that teplizumab may also benefit newly diagnosed patients by protecting remaining beta cells, which could ease blood sugar control and reduce long-term risks.

Experts emphasize the importance of making teplizumab accessible on the NHS and implementing screening programs to identify early-stage T1D for optimal benefit.

Delaying progression to stage 3 T1D can help prevent or delay the need for lifelong insulin therapy, reduce hypoglycemia episodes, and lower long-term complication risks.

The MHRA will continue to monitor the safety and effectiveness of teplizumab closely, encouraging reporting of side effects through its Yellow Card scheme.

Anyone experiencing side effects is advised to consult healthcare professionals and report to the MHRA Yellow Card scheme.

Sanofi’s General Manager for UK and Ireland highlighted that this approval marks a major advancement in diabetes care, comparable to the impact of insulin a century ago, with hopes for timely access in England and Wales.

Experts stress the importance of making teplizumab accessible on the NHS and supporting early screening programs to maximize its benefits.

The MHRA’s approval was granted through its international recognition procedure, involving trusted regulatory partners to ensure robust evidence for UK patients.