European Commission Extends Licence For ONGLYZATM (Saxagliptin)

The European Commission has granted a licence extension for Bristol-Myers Squibb and AstraZeneca's oral antidiabetic ONGLYZATM (saxagliptin) to include Type 2 diabetes patients with moderate or severe renal impairment. It is estimated that more than 25% of patients with Type 2 diabetes have moderate or severe renal impairment[1] and, as a result, have limited therapeutic options to manage their diabetes.[2],[3] 

Commenting on the approval, Professor Steve Bain, Chair in Medicine (Diabetes) at Swansea University's College of Medicine, said, "Although renal impairment is an issue facing more than one in four of our patients, a number of common diabetes treatments can't be used in this group. The European Commission decision will provide physicians with a welcome treatment option to optimise patient care and means saxagliptin will be the only gliptin (otherwise known as a DPP-4 inhibitor) available for Type 2 diabetes patients with moderate and severe renal impairment." 

While no dose adjustment will be required for the existing antidiabetic medication (saxagliptin 5mg) for patients with mild renal impairment, those with moderate or severe renal impairment (defined by a creatinine clearance level of <50ml/min), will be required to take a half dose, in the form of a saxagliptin 2.5mg tablet daily. Since the dose of saxagliptin should be limited to 2.5mg based upon renal function, patients' renal function should be assessed prior to treatment commencing and, in keeping with routine care, monitored regularly after treatment has been initiated. 

As experience in patients with severe renal impairment is very limited, saxagliptin should be used with caution in this population and is not recommended for patients with end-stage renal failure. 

The licence extension is supported by a 12-week study with an extension to 52 weeks of once-daily saxagliptin 2.5mg compared with placebo.[4] 

According to Dr Neil Munro, Associate Specialist in Diabetes at the Chelsea and Westminster Hospital and a GP in Surrey, "Patients with Type 2 diabetes and renal impairment present a significant challenge for doctors whose treatment choices need to balance efficacy with side effects. Through effective control of blood sugar levels, saxagliptin provides another treatment option in a patient population where few glucose lowering therapies are currently licensed."