The European Commission has approved Teizeild, Sanofi's monoclonal antibody therapy, for use in the EU to slow progression of stage 2 type 1 diabetes in adults and children over eight.

Teizeild is given by infusion and works by modulating the autoimmune response to slow progression rather than cure, delaying transition to stage 3 that requires insulin.

In the pivotal trial, 57% of Teizeild-treated patients remained at stage 2 by the study’s end, versus 28% on placebo, signaling a meaningful treatment effect.

Sanofi acquired Provention Bio in 2023 for $2.9 billion to bolster its position in diabetes and immune-related diseases.

Before EU approval, Teizeild had already been approved in the United States, United Kingdom, China, Canada, Israel, Saudi Arabia, the United Arab Emirates, and Kuwait.

Global seven-market type 1 diabetes sales are projected to reach about $9.9 billion by 2033, with the United States likely accounting for up to 91.6% of demand driven by late-stage products and immunomodulatory agents.

Approval hinges on TN-10 trial results showing Teizeild delays progression to stage 3 by a median of about two years versus placebo.