EU Approval for Komboglyze and Onglyza

AstraZeneca and Bristol-Myers Squibb are celebrating after European regulators approved two of their diabetes drugs.

AstraZeneca and Bristol-Myers Squibb Company announced today that the European Commission has granted marketing authorisation for Komboglyze,  which combines the DPP-4 inhibitor Onglyza (saxagliptin) with metformin in a once-a-day tablet.

The combination is to be used as an adjunct to diet and exercise in order to improve the glycaemic control in adults with type two diabetes,  which is inadequately controlled on their maximally tolerated dose of metformin alone, or those who are currently being treated with the combination of Onglyza and metformin as separate capsules.

The approval is centred on trials that involved 4,326 patients, where saxagliptin and metformin were administered as separate components. The bioequivalence of Komboglyze to co-administered saxagliptin and metformin was demonstrated in further studies.

The Komboglyze approval was announced hours after the European Commission gave the green light to Onglyza yesterday for use as a combination treatment with insulin to improve glycaemic control in adult patients with type 2 diabetes.

The expanded authorisation was based on Phase IIIb 24-week data which showed that Onglyza 5mg added to insulin (with or without metformin) considerably reduced blood sugar levels, compared to treatment with placebo added to insulin (with or without metformin).

The quantity of patients who experienced a minimum of one adverse side effect was similar between the two treatment groups.

Brian Daniels, head of global development and medical affairs at B-MS, noted that “since many patients with type 2 diabetes eventually require insulin, it is important that anti-diabetic treatments can be used with insulin to help patients who are inadequately controlled on their current regimen”.

By the end of 2011, diabetes is estimated to affect almost 53 million people aged 20-79 in Europe, and this figure is expected to rise to more than 64 million by 2030.Type 2 diabetes accounts for roughly 90 to 95% of all cases of identified diabetes in adults.


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