EMA to review Sanofi’s type I diabetes therapy

The European Medicines Agency has accepted for review Sanofi's experimental type I diabetes therapy sotagliflozi.

If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with the condition.

Developed in partnership with Lexicon Pharmaceuticals, sotagliflozin is an investigational dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys process blood sugar (glucose).

The submission contains data from the inTandem clinical trial programme, in which three Phase III clinical trials assessed the drug’s safety and efficacy in around 3,000 adults with the poorly controlled type I diabetes.

In one trial, a significantly larger proportion of patients in the sotagliflozin group achieved the primary endpoint - a glycated haemoglobin level lower than 7 percent at week 24, with no episodes of severe hypoglycaemia or diabetic ketoacidosis after randomisation - than in the placebo group (28.6 percent versus 15.2 percent).

"Despite recent advances, the challenges of type I diabetes management prevent many patients from reaching their treatment goals. There is a need for therapies to be used in addition to insulin to help people with type I diabetes better control their blood sugar," said Jorge Insuasty, global head of Development, at Sanofi.

"Sotagliflozin is the first SGLT-1/2 dual inhibitor to be accepted for regulatory review in Europe… We look forward to working with the EMA through the review process to bring this potential treatment to patients".

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