European Commission Grants Marketing Authorisation For Onglyza
Launch of Onglyza is expected to begin in the fourth quarter of 2009
AstraZeneca and Bristol-Myers Squibb have reported that the European Commission has granted marketing authorisation for Onglyza (saxagliptin) across 27 countries of the EU.
Onglyza is indicated as a once-daily 5mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control.
Reportedly, 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 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. The launch of ONGLYZA is expected to begin in the fourth quarter of 2009.
Beatrice Cazala, president, Bristol-Myers Squibb, Europe, and president, Global Commercialisation, said: “The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca.”
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