FDA Approves Tzield to Slow Progression of Type 1 Diabetes in Pediatric Patients

The U.S. Food and Drug Administration has given accelerated approval to Tzield, a medication designed to delay the reduction of natural insulin production in children aged 8 to 17 with recently diagnosed stage 3 type 1 diabetes. This decision marks an expansion for the first disease-modifying therapy for autoimmune type 1 diabetes. The approval is supported by data from the Phase 3 PROTECT trial and extensive clinical development involving over 900 patients.