Onglyza Gains Approval in EU

Bristol-Myers Squibb and AstraZeneca were granted marketing authorization for Onglyza from the European Commission. Onglyza is indicated as a once-daily 5 mg tablet in adult patients with type 2 diabetes to improve glycaemic control in combination with metformin, sulphonylurea or thiazolidinedione, when these drugs alone, with diet and exercise, do not provide adequate glycaemic control.

The marketing authorization is based on data from six Phase III registrational trials and a Phase IIIb study comparing saxagliptin plus metformin with sitagliptin plus metformin. The 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 drug to be launched in Europe through BMS and AZ’s worldwide R&D collaboration. Onglyza will be launched in 4Q09.

Béatrice Cazala, BMS president, Europe, and president, global commercialization, 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.”