Overview
- FDA regulators widened Tzield’s label Wednesday to cover children 1 to 7 with stage 2 type 1 diabetes, allowing use to delay progression to stage 3.
- Regulators cited interim PETITE-T1D data in 15 children that showed an 89.6% chance of avoiding stage 3 over about a year with no grade 4 or 5 side effects.
- The ongoing phase 4 study has enrolled 23 children under eight who receive a daily intravenous infusion for 14 days.
- Investigators note the small, single‑arm design limits certainty, and longer follow‑up is needed to confirm how long benefits and safety last.
- The FDA is also reviewing Tzield for people eight and older soon after a stage 3 diagnosis, and advocates are urging earlier screening to find eligible children.