Bristol-Myers Squibb Company and AstraZeneca have announced that the European Commission has granted marketing authorisation for Onglyza in the 27 countries of the European Union.
Onglyza is indicated as a once-daily 5mg 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.
Onglyza is the first medicine to be launched in Europe through the worldwide collaboration of Bristol-Myers Squibb and AstraZeneca to enable the companies to research, develop and commercialise select investigational medicines for the treatment of type 2 diabetes.
Béatrice Cazala, Bristol-Myers Squibb’s President Europe, and President, Global Commercialisation said: “The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca. Our legacy in treating type 2 diabetes and cardiovascular disease, together with our knowledge and expertise, enables us to deliver to patients a medicine that will offer further choice for the treatment of this serious condition.”
Ulf Sather, AstraZeneca’s Regional Vice President for Europe said: “Diabetes is a growing epidemic currently affecting some 53 million people in Europe with the number of cases expected to increase. Today’s announcement is good news for those affected by type 2 diabetes and further demonstrates the commitment of AstraZeneca and Bristol-Myers Squibb to bring much needed options for the treatment of type 2 diabetes.”
Onglyza belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body’s ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver’s production of glucose.
The launch of Onglyza is expected to begin in the fourth quarter of 2009.