US prescribing info update for Onglyza

The US Food and Drug Administration (FDA) has approved an update to prescribing information for Onglyza (saxagliptin), a type 2 diabetes therapy from AstraZeneca (AZ) and Bristol-Myers Squibb (BMS).

The prescribing information will be updated to reflect data from two clinical studies, the first of which investigated the safety and efficacy of Onglyza in patients with moderate to severe renal impairment or end-stage renal disease (ESRD). Data at 12 weeks showed that Onglyza 2.5mg once-daily significantly improved glycosylated haemoglobin (HbA1c) from baseline compared to placebo when added to patients' current diabetes treatment.

The second study, which took place over 52 weeks, compared Onglyza to titrated glipizide in patients with inadequate glyceamic control on metformin therapy plus diet and exercise. Data showed that Onglyza plus metformin provided similar HbA1c reductions from baseline. Onglyza plus metformin also resulted in significantly less confirmed hypoglycaemia, as well as weight loss compared to weight gain versus titrated glipizide plus metformin.  

Onglyza was approved by the FDA in July 2009 as an adjunct to diet and exercise to improve glyceamic (blood sugar) control in adults with type 2 diabetes mellitus in multiple clinical settings. 

Onglyza is approved in 56 countries, including the US, Canada, Mexico, Chile, India, Brazil, Argentina and 30 European nations and has been submitted for regulatory review in more than 87 countries.

Bristol-Myers Squibb and AstraZeneca produce Onglyza in partnership as part of a collaboration set up between the two companies in January 2007 to research, develop and commercialise select investigational drugs for type 2 diabetes.