2011-03-04

ONGLYZA(R) Becomes the First DPP-4 Inhibitor Available for Use in Europe


Paris and London (ots/PRNewswire) - Bristol-Myers SquibbCompany (http://www.bms.com) and AstraZeneca(http://www.astrazeneca.com) today announced that the EuropeanCommission has approved a label update for ONGLYZA(R) (saxagliptin)in the treatment of adults with type 2 diabetes who have moderate orsevere renal impairment. The approved dosage for the patient group isa 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 withmoderate or severe renal impairment. ONGLYZA is indicated in adultpatients with type 2 diabetes mellitus to improve glycaemic controlin combination with metformin, sulphonylurea, or thiazolidinedione,when each treatment alone, with diet and exercise, does not provideadequate glycaemic control.

This label update was granted on the basis of clinical datasubmitted to the European Medicines Agency (EMA) from a 12-week,multi-centre, randomized, double-blind, placebo-controlled study toevaluate the treatment effect of ONGLYZA 2.5 mg once-daily comparedwith placebo in 170 patients with type 2 diabetes and renalimpairment (creatinine clearance [CrCl] less than or equal to 50mL/min). In this study, 98.2% of the patients were treated with otherantihyperglycaemic medication. The results of the study, which aredescribed in the Summary of Product Characteristics (SmPc),demonstrated that ONGLYZA 2.5 mg was safe and effective, comparedwith placebo, in adults with type 2 diabetes who have moderate orsevere renal impairment.

According to routine clinical care, assessment of renal functionis recommended in type 2 diabetes patients and the dose of ONGLYZAshould be adjusted accordingly. No dose adjustment is recommended forpatients with mild renal impairment. For patients with moderate orsevere renal impairment, the dose of ONGLYZA is 2.5 mg once daily.

The use of ONGLYZA in patients with severe renal impairment isvery limited. Therefore, ONGLYZA should be used with caution in thispopulation. ONGLYZA is not recommended for patients with end-stagerenal disease (ESRD) requiring hemodialysis.

About ONGLYZA

ONGLYZA has been submitted for regulatory review in more than 87countries and is approved in 56 countries, including the UnitedStates, Canada, Mexico, 30 European countries, Chile, India, Braziland Argentina.

ONGLYZA is indicated as a once-daily 5 mg oral tablet dose inadult patients with type 2 diabetes mellitus to improve glycaemiccontrol:

- 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 insulintherapy.

Please see the Summary of Product Characteristics for the fullprescribing information.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaborationin January 2007 to enable the companies to research, develop andcommercialise select investigational drugs for type 2 diabetes. TheBristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicatedto global patient care, improving patient outcomes and creating a newvision for the treatment of type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whosemission is to discover, develop and deliver innovative medicines thathelp patients prevail over serious diseases. About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceuticalbusiness with a primary focus on the discovery, development andcommercialisation of prescription medicines for gastrointestinal,cardiovascular, neuroscience, respiratory and inflammation, oncologyand infectious disease. AstraZeneca operates in over 100 countriesand its innovative medicines are used by millions of patientsworldwide. For more information please visit:http://www.astrazeneca.com.

ONGLYZA is a registered trademark of the Bristol-Myers SquibbCompany.

Contacts:

Media: Carmel Hogan, Bristol-Myers Squibb, +33-158-836-555,carmel.hogan@bms.com

Jim Minnick, AstraZeneca, +1-302-885-5135,jim.minnick@astrazeneca.com

Investors: John Elicker, Bristol-Myers Squibb, +1-609-252-4611,john.elicker@bms.com

Karl Hard, AstraZeneca, +44-20-7604-8123,karl.j.hard@astrazeneca.com

ots Originaltext: Bristol-Myers Squibb and AstraZenecaIm Internet recherchierbar: http://www.presseportal.de

Contact:Contacts: Media: Carmel Hogan, Bristol-Myers Squibb,+33-158-836-555, carmel.hogan@bms.com; Jim Minnick, AstraZeneca,+1-302-885-5135, jim.minnick@astrazeneca.com; Investors: John Elicker,Bristol-Myers Squibb, +1-609-252-4611,john.elicker@bms.com; Karl Hard, AstraZeneca,+44-20-7604-8123,karl.j.hard@astrazeneca.com

Bristol-Myers Squibb and AstraZeneca

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ONGLYZA(R) Becomes the First DPP-4 Inhibitor Available for Use in Europe

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