AstraZeneca
and Bristol-Myers Squibb Company announced that the European Commission
has approved a label update for Onglyza (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.
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] <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.
Onglyza has been submitted for regulatory review in more than 87 countries and is approved in 56 countries, including the United States, Canada, Mexico, 30 European countries, Chile, India, Brazil and Argentina.
Onglyza is indicated in the EU as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.
