FDA Approval Opens New Treatment Path for Children with Type 1 Diabetes

The U.S. Food and Drug Administration has recently approved a new use for Tzield, a drug for children and teenagers aged 8 to 17 who have already been diagnosed with type 1 diabetes. The treatment is intended to slow damage to the pancreatic cells that produce insulin, helping preserve the body’s own insulin production for longer.

At Schneider Children’s Medical Center, doctors welcomed the move and said Israeli children may be able to benefit soon. Dr. Tal Oron, senior endocrinologist at the center and leader of the ADIR study, said, “This approval is an opening to an era in which we do not just treat diabetes, but try to delay it, and perhaps in the future even prevent it.” He noted that when children are diagnosed, many have already lost about 75% of their functioning pancreatic cells.

The drug does not cure type 1 diabetes, but it may reduce insulin needs over time, improve glucose control, and lower the risk of future complications. Until now, treatment has mainly focused on insulin injections after much of the pancreatic damage had already occurred. Schneider said this is the first approved treatment aimed at changing the course of the disease after diagnosis.

In the Israeli ADIR research program, blood tests are used to look for antibodies that indicate the start of the autoimmune process. Researchers say a simple blood test can estimate type 1 diabetes risk with about 85% accuracy. Early diagnosis may also reduce emergencies, since about 40% of newly diagnosed children already arrive with diabetic ketoacidosis, a life-threatening condition with possible long-term neurological and cognitive effects.

Oron said about 600 children and 600 adults are diagnosed with type 1 diabetes in Israel each year. Tzield is not yet included in the Israeli health basket, though he said it may be available in some cases through private insurance. The treatment is very expensive, with current costs estimated at about 500,000 shekels and possibly around 1 million shekels for two courses. Oron said he expects it may enter the health basket within a few years.