Anvisa Approves Tzield, First Therapy to Delay Onset of Type 1 Diabetes

Overview

• Approval covers patients aged 8 and older who are in stage 2, the pre‑symptomatic phase of type 1 diabetes.
• Tzield (teplizumab) is the first immunomodulatory treatment authorized in Brazil to alter the course of type 1 diabetes.
• A pivotal trial showed a median two‑year delay to clinical disease and a 59% reduction in progression to insulin use versus placebo.
• The monoclonal antibody works by modulating the immune response to help preserve insulin‑producing beta cells.
• Patient access will depend on CMED price setting and subsequent rollout, and experts call for broader autoantibody screening to find eligible candidates.