The European Medicines Agency (EMA) has recommended granting marketing authorization in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and children aged eight and older who possess stage 2 type 1 diabetes.
Type 1 diabetes is a chronic autoimmune condition characterized by the immune system’s destruction of pancreatic beta cells, which produce insulin—a hormone essential for regulating blood glucose levels by facilitating glucose entry into cells for energy production. This malfunction leads to elevated blood glucose levels, resulting in symptoms such as increased thirst, hunger, frequent urination, weight loss, and fatigue. Over time, the disease can adversely affect major organs, including the heart, blood vessels, nerves, eyes, and kidneys. Daily insulin injections become necessary to manage blood glucose levels.
The disease typically arises in childhood but can manifest at any age. It progresses through three stages, with symptoms generally appearing at stage 3, necessitating daily insulin administration. This progression poses a considerable burden on patients and their caregivers, especially children. Delaying the onset of stage 3, particularly in pediatric cases, is advantageous in diabetes management. Approximately 2.2 million individuals in the EU are living with type 1 diabetes, with no authorized treatments currently available to delay or cure the illness.
Teizeild’s active substance, teplizumab, works as an antibody that slows disease progression by diminishing the rate at which pancreatic beta cells are destroyed. The treatment involves intravenous infusion administered once daily over a 14-day period.
Common side effects associated with Teizeild include low levels of white blood cells (lymphocytes, leucocytes, and neutrophils), as well as rash. A notable serious adverse reaction, cytokine release syndrome, has been documented in 2% of patients, causing symptoms such as fever, vomiting, shortness of breath, headache, and hypotension. The product information and risk management plan for Teizeild incorporate appropriate measures to mitigate risks. Sanofi Winthrop Industrie is the applicant for Teizeild.
(Source: EMA)
