In March 2011 The European Commission extended the licence for Onglyza (saxagliptin) to allow its use in patients with Type 2 diabetes and moderate or severe renal impairment. Onglyza, a dipeptidyl peptidase 4 (DPP-4) inhibitor, manufactured by AstraZeneca and Bristol-Myers Squibb, is the first in its class to be licensed for use in this patient population.
It can be used in combination with metformin, sulphonylurea or thiazolidinedione, but not indicated in combination with insulin therapy.
No dosage adjustment is required for Onglyza in mild renal impairment; however, in moderate to severe impairment a reduced dose of 2.5mg once daily is recommended. Caution is advised in patients with severe renal impairment and use in patients with end-stage renal disease (ESRD) requiring dialysis is not recommended. Renal function should be monitored prior to initiation of therapy and periodically thereafter.
Approval for the licence extension was based on the results of a 12-week randomised controlled study, which showed that saxagliptin 2.5mg is a well-tolerated treatment option for patients with inadequately controlled Type 2 diabetes and renal impairment.
For more information contact www.astrazeneca.com or www.bms.com