EU approves Teizeild for patients with stage 2 type 1 diabetes – Sanofi
The European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with stage 2 T1D. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Teizeild is the first T1D disease-modifying therapy approved in the EU, marking a significant milestone in the treatment of this progressive autoimmune disease. The approval is based on positive results from the TN-10 phase II study (clinical study identifier: NCT01030861) demonstrating that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo, in adults and children aged eight years and older with stage 2 T1D.
“We are pleased that, for the first time, we will be able to offer patients and families in the EU a disease-modifying therapy designed to address the underlying immune process of type 1 diabetes,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “We remain committed to working with external stakeholders across the EU to bring patients the benefits of Teizeild, a unique therapy that may prevent the natural progression of type 1 diabetes by protecting beta-cell function.”
At the end of the TN-10 phase II study, the proportion of patients who remained in stage 2 T1D was almost twice as high in the Teizeild group as in the placebo group (57% vs 28%). The safety profile was consistent with the one observed in previous studies of Teizeild. The most frequently observed adverse events were blood or bone marrow-related (transient lymphopenia) in 75% of the participants and dermatologic or skin-related (rash) in 36% of the participants.
Teizeild (known as Tzield outside the EU) is also approved in the US, the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait to delay the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 T1D. As previously communicated, following the positive CHMP recommendation for this newly approved indication, Sanofi has decided not to progress with a second application for Teizeild in recently diagnosed stage 3 T1D at this time. Next steps are under evaluation. Other regulatory reviews are ongoing.
The pivotal TN-10 phase II study was a randomized, placebo-controlled, double-blind study which evaluated Teizeild for the delay of stage 3 T1D in adults and children aged eight years and older diagnosed with stage 2 T1D (presence of at least two T1D-related autoantibodies and dysglycemia) who are relatives of people living with autoimmune T1D. Seventy-six participants aged eight to 45 were enrolled (Teizeild n=44, placebo n=32). They were randomized to receive a single 14-day course of either Teizeild or placebo. The primary endpoint was the elapsed time from randomization to the clinical diagnosis of autoimmune stage 3 T1D (progression from stage 2 T1D to stage 3 T1D). Key secondary end points included safety and tolerability. Results demonstrated that the median time to the diagnosis of stage 3 T1D was 48.4 months in the Teizeild group and 24.4 months in the placebo group. The disease was diagnosed in 19 (43%) of the participants who received Teizeild and in 23 (72%) of those who received placebo. The hazard ratio for the diagnosis of type 1 diabetes (Teizeild vs. placebo) was 0.41 (95% CI: 0.22 to 0.78; p=0.006 by adjusted Cox proportional-hazards model). There were expected adverse events of rash and transient lymphopenia.
