FDA approves wider use of Sanofi's Tzield in newly diagnosed type 1 diabetes patients

The US Food and Drug Administration has approved an expanded label for Sanofi's (SNY) type 1 diabetes treatment Tzield, allowing its use in children aged 8 to 17 who have recently been diagnosed with stage 3 of the disease.

The regulator first cleared the injectable drug in 2022 to delay progression from stage 2 to stage 3 type 1 diabetes in patients aged eight and older, and has since broadened its approved uses. In April the FDA authorized the drug to delay onset of stage 3 disease in children as young as one. Friday's decision extends Tzield's use to those already diagnosed with stage 3, with the goal of slowing further loss of insulin production.

Type 1 diabetes is a chronic autoimmune condition in which the pancreas produces little or no insulin. Stage 3, the most advanced phase, typically brings symptoms such as frequent urination, excessive thirst and fatigue, and usually requires patients to begin insulin therapy. Tzield works by dampening the immune response that destroys insulin-producing cells in the pancreas, helping preserve the body's natural insulin output for longer.

The latest approval rests on a study of 328 children and adolescents diagnosed within the previous six weeks. Those treated with Tzield showed a smaller decline in insulin-producing cell function after about 18 months than those given a placebo.

The drug remains under regulatory watch, however. It carries a boxed warning, the FDA's strongest safety label, following reports of serious, life-threatening viral infections in some patients, including Epstein-Barr virus and cytomegalovirus.