4. March 2011 14:33
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, making the drug the first dipeptidyl peptidase-4 (DPP-4) inhibitor in Europe available in this indication.
Onglyza is approved to treat 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 based on clinical data, which 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.
It was also recommended that an assessment of renal function should be conducted in type 2 diabetes patients and the dose adjusted accordingly. The EC ruled that Onglyza should be used with caution in patients with severe renal impairment. It not recommended for patients with end-stage renal disease (ESRD) requiring hemodialysis.
Onglyza is the product of a diabetes collaboration between AstraZeneca and Bristol-Myers Squibb. It was first approved in the EU in October 2009.