AstraZeneca and Bristol-Myers Squibb are celebrating after regulators in Europe gave approvals for two of their diabetes drugs.
First up, European Commission has granted marketing authorisation for Komboglyze, which combines the firms' DPP-4 inhibitor Onglyza (saxagliptin) with metformin in a once-a-day pill. The combo is to be used as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of Onglyza and metformin as separate tablets.
The approval is based on trials that involved 4,326 patients, and the bioequivalence of Komboglyze to co-administered saxagliptin and metformin was demonstrated in additional studies.
The Komboglyze approval came hours after the European Commission gave the green light to Onglyza for use as a combination therapy with insulin to improve glycaemic control in adult patients with type 2 diabetes.
The expanded approval was based on Phase IIIb 24-week data which showed that Onglyza added to insulin significantly reduced blood sugar levels. 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".