The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Teizeild (teplizumab) for delaying the progression to stage 3 Type 1 diabetes (T1D) in adults and children aged eight years and older who have stage 2 T1D.
This recommendation is backed by results from the phase 2 TN-10 study (NCT01030861), which showed that Teizeild significantly postponed the onset of stage 3 T1D by a median of about two years compared with placebo. By the end of the study, twice as many patients in the Teizeild group remained in stage 2 T1D versus those on placebo (57% vs 28%). The safety findings were consistent with prior research, with the most common adverse events involving transient lymphopenia and rash.
“We are encouraged by the positive opinion in stage 2 T1D, which represents an important step toward transforming the 100-year-old treatment paradigm for autoimmune T1D,” said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi. “By targeting the disease at an early stage, Teizeild can help prevent the natural progression of T1D, extending the time patients can stay independent of insulin.”
Teizeild—marketed as Tzield outside the EU—is a CD3-directed monoclonal antibody already approved in multiple countries, including the US, UK, China, Canada, Israel, Saudi Arabia, the UAE, and Kuwait, for delaying progression to stage 3 T1D in eligible patients. Following discussions with the EMA, Sanofi has decided not to advance its application for recently diagnosed stage 3 T1D at this time and is assessing next steps. Additional regulatory submissions are currently under review in several other regions worldwide.
Also Read
