Prime Highlights
- FDA approved Tzield for children recently diagnosed with stage 3 diabetes.
- Tzield carries a boxed warning over serious viral infection risks.
Key Facts
- Tzield is a type 1 diabetes drug made by Sanofi.
- Study of 328 children showed slower insulin decline with Tzield.
Background
Tzield, a type 1 diabetes injection made by Sanofi, has now received the Food and Drug Administration’s approval for its use among children between the ages of 8 and 17 years old, newly diagnosed with stage 3 of the disease.
The FDA first approved Tzield in 2022 to delay the progression of type 1 diabetes from stage 2 to stage 3 in patients aged 8 and above. Since then, the drug’s approved use has been expanded several times. In April, the regulator allowed its use in children as young as one year old to delay progression to stage 3.
The newest approval permits use of the drug in children who have just been diagnosed with stage 3 disease, intending to slow the loss of insulin production.
When the pancreas produces little or no insulin, type 1 diabetes develops. Patients in stage 3 often experience symptoms such as frequent urination, excessive thirst and tiredness, and usually need insulin therapy to manage these symptoms.
Tzield works by targeting the immune response responsible for damaging insulin-producing cells in the pancreas, helping the body maintain its own insulin production for a longer period.
The latest approval was based on a study involving 328 children and teenagers diagnosed within the previous six weeks. Those who received the drug showed a smaller decline in insulin-producing cell function after around 18 months, compared with those given a placebo.
The drug carries a boxed warning, the FDA’s strongest safety alert, following reports of serious viral infections, including Epstein-Barr virus and cytomegalovirus, in some patients.
