The European Commission approved a label update for ONGLYZA (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment following results of a new study submitted by AstraZeneca and Bristol-Myers Squibb Company. 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 glycemic control in combination with metformin, sulphonylurea, or thiazolidinedione, when each treatment alone, with diet and exercise, does not provide adequate glycemic 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] <50 mL/min). In this study, 98.2% of the patients were treated with other antihyperglycemic 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.