🆕 FDAapproves the anti-CD3 monoclonal antibody teplizumab-mzwv to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition. MedTwitter
"Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, andin the FDA's Center for Drug Evaluation and Research."The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.
The agent, which interferes with T-cell-mediated autoimmune destruction of pancreatic beta cells, is the first disease-modifying therapy for impeding progression of type 1 diabetes. It is administered by intravenous infusion once daily for 14 consecutive days. The specific indication is"to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes." In type 1 diabetes staging, adopted in 2015,with two or more islet autoantibodies with normoglycemia, stage 2 is beta-cell autoimmunity with dysglycemia yet asymptomatic, and stage 3 is the onset of symptomatic type 1 diabetes.
Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical type 1 diabetes and a 75% risk of developing the condition within 5 years.
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