November 20, 2025

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

IntelME Verdict

Regulatory Approval

TL;DR

European Medicines Agency's CHMP issues positive opinion for Teizeild (teplizumab) to delay stage 3 type 1 diabetes onset, potentially becoming EU's first disease-modifying T1D therapy.

Analysis

The positive opinion by the CHMP for Teizeild (teplizumab) to delay stage 3 type 1 diabetes onset signifies a significant regulatory milestone. If approved, it would be the EU's first disease-modifying therapy for T1D, offering new treatment options and potentially impacting the landscape of T1D management and future drug development strategies.