November 20, 2025

Human medicines European public assessment report (EPAR): Teizeild, teplizumab, Status: Opinion

IntelME Verdict

Clinical Breakthrough

TL;DR

European Medicines Agency's CHMP issues positive opinion recommending approval of Teizeild (teplizumab) for delaying stage 3 type 1 diabetes onset in adults and children, potentially the first EU-approved disease-modifying T1D therapy.

Analysis

The positive opinion recommending Teizeild (teplizumab) for delaying stage 3 type 1 diabetes onset marks a significant advancement in T1D treatment. If approved, this could be the first disease-modifying therapy for T1D in the EU, offering new hope for patients and potentially changing the landscape of T1D management.