AstraZeneca receives CHMP backing for new combination diabetes therapy

AstraZeneca has received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval of its new diabetes therapy.

The committee has offered a positive opinion endorsing a tablet-based fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adults with type 2 diabetes.

Potentially, this could be the first DPP-4i/SGLT-2i combination product to be approved in Europe. It is intended to improve glycaemic control in cases where other therapies have not provided adequate glycaemic control, or when a patient is already being treated with a free combination of saxagliptin and dapagliflozin.

Results from three studies in type-2 diabetes have demonstrated the glycaemic control benefits associated with the new combination therapy when compared to established treatment strategies.

A final decision from the European Commission is now expected within the next few months.

This comes after AstraZeneca received a recommendation from the CHMP for its new pandemic live attenuated influenza vaccine last month.