Sanofi's Teizeild Gains EU Backing for Type 1 Diabetes Breakthrough

Sanofi’s type 1 diabetes therapy Teizeild (teplizumab) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

This makes Teizeild the first disease-modifying therapy to type 1 diabetes in the EU, a historic move in the industry. The decision of CHMP is based on the TN -10 phase-2 trial.

The trial included 76 patients between the ages of 8 to 45 years of age, and with a type 2 diabetes stage 1. The study involved one 14 days long infusion of Teizeild. This drug increased the median progression to stage 3 more than twice, increasing the time compared to placebo which was approximately 25 months by almost 50 months.

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At the study termination, 57 per cent of the patients under Teizeild stayed in stage 2, compared to 28 per cent of the patients under placebo. There were safety data that Teizeild was well tolerated. Some of the common side effects were transient lymphopenia, rash, leukopenia and neutropenia. More severe problems like cytokine-release syndrome were reported, but they could be handled in the study.

Sanofi stressed the significance of the early intervention of type 1 diabetes. Through the therapy, the natural progression of the disease may be slowed down and the insulin-producing capacity may be extended. Early intervention of the disease will allow Teizeild to prevent the traditional course of the disease and allow patients to be insulin-independent longer, explains the Olivier Charmeil, Executive Vice President of General Medicines at Sanofi.

Teizeild has advanced thanks to the PRIME scheme of EMA that helps to fund the treatment of unmet medical needs. The recommendation has now been passed to the European Commission where the final marketing-authorization decision has been established, which will culminate into a significant change in diabetes management in Europe.