ONGLYZA (saxagliptin) Receives Marketing Authorisation in Europe for the Treatment of Type 2 Diabete , Astra Zeneca

Release Date: 2009-10-05

AstraZeneca and Bristol-Myers Squibb Company announced today that the European Commission has granted marketing authorisation for ONGLYZA (saxagliptin) in the 27 countries of the European Union.
ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control.

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.

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.”

Béatrice Cazala, Bristol-Myers Squibb’s 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.”
Type: NORMAL
Company: Astra Zeneca
Country: Italy
 
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