French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that the European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and children eight years and older with stage 2 T1D.

This approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and is based on the TN-10 phase 2 study, which showed a median two-year delay in progression to stage 3 compared with placebo.

In the study, 57% of patients receiving Teizeild remained in stage 2 T1D versus 28% in the placebo group. The safety profile was consistent with prior trials, with the most common adverse events being transient lymphopenia in 75% of participants and rash in 36%.

Teizeild (known as Tzield outside the EU) is also approved in the US, UK, China, Canada, Israel, Saudi Arabia, UAE, and Kuwait. It represents the first disease-modifying therapy for T1D in the European Union.

Sanofi said that it has opted not to pursue a second application for Teizeild in recently diagnosed stage 3 T1D at this time. Other regulatory reviews are ongoing.