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ONGLYZA(R) Becomes the First DPP-4 Inhibitor Available for Use in Europe
Paris and London (ots/PRNewswire) - Bristol-Myers Squibb Company (http://www.bms.com) and AstraZeneca (http://www.astrazeneca.com) today announced that the European Commission has approved a label update for ONGLYZA(R) (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. The approved dosage for the patient group is a new once-daily 2.5 mg dose.
ONGLYZA will be the first dipeptidyl peptidase-4 (DPP-4) inhibitor in Europe available for type 2 diabetes patients with moderate or severe renal impairment. ONGLYZA is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, sulphonylurea, or thiazolidinedione, when each treatment alone, with diet and exercise, does not provide adequate glycaemic control.
This label update was granted on the basis of clinical data submitted to the European Medicines Agency (EMA) from a 12-week, multi-centre, randomized, double-blind, placebo-controlled study to evaluate the treatment effect of ONGLYZA 2.5 mg once-daily compared with placebo in 170 patients with type 2 diabetes and renal impairment (creatinine clearance [CrCl] less than or equal to 50 mL/min). In this study, 98.2% of the patients were treated with other antihyperglycaemic medication. The results of the study, which are described in the Summary of Product Characteristics (SmPc), demonstrated that ONGLYZA 2.5 mg was safe and effective, compared with placebo, in adults with type 2 diabetes who have moderate or severe renal impairment.
According to routine clinical care, assessment of renal function is recommended in type 2 diabetes patients and the dose of ONGLYZA should be adjusted accordingly. No dose adjustment is recommended for patients with mild renal impairment. For patients with moderate or severe renal impairment, the dose of ONGLYZA is 2.5 mg once daily.
The use of ONGLYZA in patients with severe renal impairment is very limited. Therefore, ONGLYZA should be used with caution in this population. ONGLYZA is not recommended for patients with end-stage renal disease (ESRD) requiring hemodialysis.
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 and Argentina.
ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control:
- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; - in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or - in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate
ONGLYZA is currently not indicated in combination with insulin therapy.
Please see the Summary of Product Characteristics for the full prescribing information.
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.
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. 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. For more information please visit: http://www.astrazeneca.com.
ONGLYZA is a registered trademark of the Bristol-Myers Squibb Company.
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