Overview
- On 13 November 2025, the CHMP issued a positive opinion recommending EU approval of the PRIME-designated therapy Teizeild from Sanofi Winthrop Industrie.
- The proposed use is to delay progression to stage 3 in adults and children aged 8 years and older who have stage 2 type 1 diabetes.
- In the TN-10 randomised trial (n=76), median time to stage 3 was 49.5 months with teplizumab versus 24.9 months with placebo.
- The product is a 1 mg/ml concentrate given as daily intravenous infusions for 14 days and must be administered by healthcare professionals with appropriate support.
- Common adverse reactions included lymphopenia, leukopenia, neutropenia, rash and low blood bicarbonate, and the most frequent serious reaction was cytokine release syndrome reported in about 2% of patients.