Komboglyze Receives EU Marketing Authorisation
The approval of KOMBOGLYZE is based on a saxagliptin development programme that involved 4,326 patients, including 2,158 individuals receiving saxagliptin plus metformin.
AstraZeneca and Bristol-Myers Squibb Company announced Tuesday that the European Commission has granted marketing authorisation for KOMBOGLYZE? that will cover the 27 Member States of the European Union.
KOMBOGLYZE combines saxagliptin (ONGLYZA?), a DPP-4 inhibitor, and metformin immediate-release (metformin IR), a biguanide, in one convenient tablet for the treatment of Type 2 diabetes.
The indication for KOMBOGLYZE is as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with Type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.
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