ONGLYZA(R) Becomes the First DPP-4 Inhibitor Available for Use in EuropeBy Bristol-myers Squibb And Astrazeneca, PRNE
Thursday, March 3, 2011
PARIS and LONDON, March 4, 2011 - Bristol-Myers Squibb Company (www.bms.com)(NYSE: BMY) and
AstraZeneca (www.astrazeneca.com) (NYSE: AZN)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)
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
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.
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:
ONGLYZA is a registered trademark of the Bristol-Myers Squibb Company.
Media: Carmel Hogan, Bristol-Myers Squibb, +33-158-836-555,
Jim Minnick, AstraZeneca, +1-302-885-5135, email@example.com
Investors: John Elicker, Bristol-Myers Squibb, +1-609-252-4611,
Karl Hard, AstraZeneca, +44-20-7604-8123, firstname.lastname@example.org
Contacts: Media: Carmel Hogan, Bristol-Myers Squibb, +33-158-836-555, carmel.hogan at bms.com; Jim Minnick, AstraZeneca, +1-302-885-5135, jim.minnick at astrazeneca.com; Investors: John Elicker, Bristol-Myers Squibb, +1-609-252-4611,
john.elicker at bms.com; Karl Hard, AstraZeneca, +44-20-7604-8123, karl.j.hard at astrazeneca.com
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