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

The U.S. Food and Drug Administration has approved a new use for Tzield, a drug now intended for children and teenagers ages 8 to 17 who have already been diagnosed with type 1 diabetes. The goal is not to cure the disease, but to slow the immune attack on pancreatic cells and preserve the body’s remaining natural insulin production for longer.

At Schneider Children’s Medical Center, doctors welcomed the decision and said Israeli children may soon be able to benefit as well. Dr. Tal Oron, a senior endocrinologist and lead researcher in the ADIR study, said, “Until now type 1 diabetes was a disease that seemed to appear out of nowhere.” He explained that by the time many children are diagnosed, only about 25% of the insulin-producing pancreatic cells are still working, and no drug had previously been able to slow that process.

Oron said the treatment does not cure diabetes, but it may reduce the need for insulin over time, improve glucose control, and lower the risk of future complications. Schneider said treatment so far has focused mainly on insulin injections after much of the pancreatic damage had already occurred, whereas this is the first approved therapy aimed at changing the disease course after diagnosis.

The ADIR research program in Israel is using blood tests to look for antibodies that signal 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 medical emergencies, since about 40% of children diagnosed today already arrive with diabetic ketoacidosis, a life-threatening condition with possible long-term neurological and cognitive effects. The study found that about 90% of those diagnosed have no family history. A family version of ADIR was expanded about a year ago to include first-degree relatives ages 2 to 45. Oron said about 600 children and 600 adults are diagnosed with type 1 diabetes in Israel each year. The drug is not yet in Israel’s health basket, but may be available in some cases through private insurance. Its current price is estimated at about 500,000 shekels, and two treatments may be needed, bringing the total to about 1 million shekels. Oron expects it could enter the health basket within a few years.