AstraZeneca: Onglyza EU Marketing Authorisation
06 October 2009 - 1:23AM
Dow Jones News
AstraZeneca PLC (AZN.LN), a pharmaceutical company, and
Bristol-Myers Squibb Company (BMY), a bio-pharmaceutical company,
announced Monday that the European Commission has granted marketing
authorisation for ONGLYZA (saxagliptin) in the 27 countries of the
European Union.
MAIN FACTS:
-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.
-The marketing authorisation is based on data submitted from a
comprehensive clinical development programme that included six core
Phase III registrational trials and a Phase IIIB study comparing
saxagliptin plus metformin with sitagliptin plus metformin.
-The registrational trials assessed the safety and efficacy of
ONGLYZA and involved 4,148 patients with type 2 diabetes, including
3,021 patients treated with ONGLYZA.
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com