Revista Salud y Bienestar

AstraZeneca, Bristol-Myers Squibb's Onglyza approved in Europe for patients with renal impairment

Por Fat
AstraZeneca and Bristol-Myers Squibb on Friday announced that Onglyza (saxagliptin) received expanded approval in Europe to include the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. The companies said the label update for the product makes it the first DPP-4 inhibitor to be approved in the EU in this indication, and follows a similar move in the US last month.
The approval was based on data submitted to the European Medicines Agency from a clinical trial comparing once-daily Onglyza with placebo in 170 patients with type 2 diabetes and renal impairment. Data from the study showed that the compound was safe and effective in this patient population.
Onglyza was initially approved in the EU in 2009 in combination with either metformin, a sulphonylurea or a thiazolidinedione, for adults with type 2 diabetes.
Reference Articles
EU okays Astra, BMS diabetes drug for kidney cases - (FinanzNachrichten)
EU approves Onglyza diabetes drug for kidney cases - (Forbes)
EU okays Astra, BMS diabetes drug for kidney cases - (London South East)
ONGLYZA Becomes the First DPP-4 Inhibitor Available for Use in Europe in Type 2 Diabetes Patients With Moderate or Severe Renal Impairment - (Yahoo!Finance)
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