NeLM news service
License extension in EU for saxagliptin (Onglyza) to include type 2 diabetes patients with moderate or severe renal impairment

Source: Bristol-Myers Squibb

Date published: 04/03/2011 16:58

Summary
by: Yuet Wan

The EC has granted a license extension for saxagliptin (OnglyzaTM) to include use in type 2 diabetes patients with moderate or severe renal impairment. It is estimated that more than 25% of patients with this disease have moderate or severe renal impairment.

 

No dose adjustment will be required for patients with mild renal impairment; those with moderate or severe renal impairment (creatinine clearance <50ml/min), will be required to halve the dose (2.5mg). 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.

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