European Commission approves BMY's ONGLYZA to treat type 2 diabetes

Bristol-Myers Squibb Company (http://www.bms.com)(NYSE: BMY) and AstraZeneca (http://www.astrazeneca.com) (NYSE: AZN)today announced that the European Commission has approved a label update for ONGLYZA(R) (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. The approved dosage for the patient group is a new once-daily 2.5 mg dose.

ONGLYZA will be the first dipeptidyl peptidase-4 (DPP-4) inhibitor in Europe available for type 2 diabetes patients with moderate or severe renal impairment. ONGLYZA is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, sulphonylurea, or thiazolidinedione, when each treatment alone, with diet and exercise, does not provide adequate glycaemic control.

This label update was granted on the basis of clinical data submitted to the European Medicines Agency (EMA) from a 12-week, multi-centre, randomized, double-blind, placebo-controlled study to evaluate the treatment effect of ONGLYZA 2.5 mg once-daily compared with placebo in 170 patients with type 2 diabetes and renal impairment (creatinine clearance [CrCl] less than or equal to 50 mL/min). In this study, 98.2% of the patients were treated with other antihyperglycaemic medication. The results of the study, which are described in the Summary of Product Characteristics (SmPc), demonstrated that ONGLYZA 2.5 mg was safe and effective, compared with placebo, in adults with type 2 diabetes who have moderate or severe renal impairment.

According to routine clinical care, assessment of renal function is recommended in type 2 diabetes patients and the dose of ONGLYZA should be adjusted accordingly. No dose adjustment is recommended for patients with mild renal impairment. For patients with moderate or severe renal impairment, the dose of ONGLYZA is 2.5 mg once daily.

The use of ONGLYZA in patients with severe renal impairment is very limited. Therefore, ONGLYZA should be used with caution in this population. ONGLYZA is not recommended for patients with end-stage renal disease (ESRD) requiring hemodialysis.