The European Medicines Agency (EMA) has recommended marketing authorization in the European Union for a medicine that can delay the progression of type 1 diabetes from stage 2 to stage 3 in adults and children aged 8 years and over.
In type 1 – stage 3 diabetes, blood sugar monitoring is imperative PHOTO: Shutterstock
The EMA announced on Friday, November 14, 2025, in a statement on its official website, that the drug, the first in its class, significantly delays the onset of stage 3 diabetes (at this stage the signs of the disease are present) and maintains the functioning of insulin-producing cells.
The drug is Teizield (teplizumab) and has already been approved in the US, Canada, the UK, China and several other countries outside the European Union, being used to delay the progression of diabetes from stage 2 (when patients have autoantibodies and dysglycemia but do not yet have clinical symptoms of diabetes) to stage 3 (when the typical signs appear and insulin therapy is required). What this drug does is significantly delay the onset of stage 3 diabetes and keep the insulin-producing cells working.
The active substance in Teizeild, teplizumab, is an antibody that delays the progression of the disease by reducing the rate at which the patient’s pancreatic beta cells self-destruct. It is given by intravenous infusion once a day for 14 consecutive days, according to the EMA website.
Teizeild has been supported through the EMA’s PRIority MEdicines (PRIME) scheme, which provides increased scientific and regulatory support for medicines that have particular potential to meet patients’ unmet medical needs. “This medicine was included in the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by the EMA to increase support for the development of medicines that target an unmet medical need. This voluntary scheme is based on increased interaction and early dialogue with developers of promising medicines to optimize development plans and speed up assessment so that these medicines can reach patients sooner”it is mentioned on the EMA website.
What is type 1 diabetes and why slowing the progression of the disease is important
Type 1 diabetes is a chronic autoimmune disease. The body’s immune system destroys the beta cells in the pancreas that produce insulin – a hormone that regulates the level of glucose (sugar) in the blood, allowing it to move into cells to produce energy. Without insulin, glucose accumulates in the blood and causes multiple symptoms: thirst, hunger, frequent urination, weight loss and fatigue. As the disease progresses, it can affect major organs in the body, including the heart, blood vessels, nerves, eyes, and kidneys. In stage 3 of the disease, patients need daily insulin injections to control their glucose levels.
This type of diabetes can occur at any age, but usually begins in childhood. It has three stages, with the above symptoms appearing in the last stage, what the drug does is significantly slow the progression from stage 2 to stage 3, making it especially useful for children.
According to the EMA, an estimated 2.2 million people in the EU are living with type 1 diabetes, and there are currently no licensed treatments to delay or cure the disease.
During the trials it was found that the average time to develop type 1 – stage 3 diabetes was 50 months in patients treated with teplizumab and 25 months in patients who received placebo.
The treatment can also cause side effects, which is why it is administered under medical supervision. The most common side effects reported with Teizeild were: low levels of different types of white blood cells (lymphocytes, leukocytes and neutrophils), skin rashes and low levels of bicarbonate in the blood, which can cause metabolic acidosis (too much acid in the body), and the most common serious side effect, reported in 2% of patients, was cytokine release syndrome (a serious condition that causes fever, vomiting, difficulty breathing, headaches and low blood pressure). “The product information and risk management plan for Teizeild includes appropriate risk mitigation measures”the EMA also shows.
The endorsement recommendation is an intermediate step in getting the treatment to the patients. The consent granted will be sent to the European Commission for the adoption of a decision on a marketing authorization at the EU level. After the marketing authorization is granted, it is up to each member state to decide on the price and inclusion in the compensation scheme.
“The applicant for Teizeild is Sanofi Winthrop Industrie. Teizeild was approved for PRIME on 17 October 2019 for the treatment of delaying or preventing clinical type 1 diabetes (T1D) in people “at risk”. On 13 November 2025, the Committee for Medicinal Products for Human Use ( CHMP ) adopted a positive opinion, recommending the granting of a marketing authorization for the medicine Teizeild, intended for the treatment of type 1 diabetes mellitus (T1DM)’. it is also specified on the website of the European Medicines Agency.
