EMA – First-in-class treatment to delay onset of type 1 diabetes
EMA has recommended granting a marketing authorisation in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and in children from 8 years of age with stage 2 type 1 diabetes.
Type 1 diabetes is a chronic autoimmune disease where the body’s immune system destroys beta cells in the pancreas that produce insulin, a hormone that regulates blood glucose (sugar) by allowing it to move into cells to produce energy. As a result, glucose builds up in the blood and causes multiple symptoms, like thirst, hunger, frequent urination, weight loss and tiredness. Over time, it can affect major organs in the body, including the heart, blood vessels, nerves, eyes and kidneys. Patients need daily insulin injections to control their glucose levels. […]
The active substance of Teizeild is teplizumab, an antibody that delays disease progression by reducing the pace of the patient’s self-destruction of pancreatic beta cells. It is administered by intravenous infusion once daily for 14 consecutive days.
Teizeild was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs.
More information on the EMA Website.





