AstraZeneca and Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has approved the inclusion of data from two clinical studies in an update to the ONGLYZA (saxagliptin) US Prescribing Information for adult type 2 diabetes patients.
The renal study investigated the safety and efficacy of ONGLYZA in patients with moderate to severe renal impairment or end-stage renal disease (ESRD). The 12-week data showed that ONGLYZA 2.5 mg once daily significantly improved glycosylated hemoglobin (HbA1c) from baseline compared to placebo when added to patients’ current diabetes treatment. In patients with ESRD, ONGLYZA and placebo showed numerically comparable reductions in HbA1c. This finding is inconclusive because the trial was not adequately powered to show efficacy within specific subgroups of renal impairment. The incidence of adverse events was similar between ONGLYZA and placebo.
The data from a separate 52-week study comparing ONGLYZA to titrated glipizide in patients with inadequate glyceamic control on metformin therapy plus diet and exercise showed that ONGLYZA plus metformin provided similar HbA1c reductions from baseline. This conclusion may be limited to patients with baseline HbA1c comparable to those in the trial. 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 is indicated as an adjunct to diet and exercise to improve blood sugar (glyceamic) control in adults with type 2 diabetes mellitus in multiple clinical settings. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (dangerously high levels of ketones in the blood or urine).
If used with an insulin secretagogue such as a sulfonylurea, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycaemia. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.
About ONGLYZA (saxagliptin)
ONGLYZA was approved by the FDA in July 2009 and is indicated as an adjunct to diet and exercise to improve blood sugar (glyceamic) control in adults for the treatment of type 2 diabetes mellitus in multiple clinical settings.
- ONGLYZA once daily can be used in combination with commonly prescribed oral anti-diabetic medications - metformin, glyburide (a sulfonylurea) or a thiazolidinedione (TZD) (pioglitazone or rosiglitazone) - or as a monotherapy to significantly reduce HbA1c levels.
- ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
ONGLYZA has been submitted for regulatory review in more than 87 countries and is approved in 56 countries, including the United States, Canada, Mexico, 30 European countries, Chile, India, Brazil, Argentina and Switzerland.
Bristol-Myers Squibb and AstraZeneca Collaboration
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes and deliver innovative medicines that help patients prevail over serious diseases.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.