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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.
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