AstraZeneca's potential blockbuster diabetes drug Onglyza approved by EC

6 October 2009

The European Commission has granted marketing authorization for Anglo-Swedish drug major AstraZeneca and US partner Bristol-Myers Squibb's Onglyza (saxagliptin) in the 27 countries of the European Union. The launch of Onglyza is expected to begin in the fourth quarter of 2009. The product, which will compete with US drug major Merck & Co's Januvia (sitagliptin) - which generated revenues of $1.75 billion last year, was approved by the US Food and Drug Administration in July this year. It launched in the USA in August.

Analysts have forecast that Onglyza sales could hit as high as $1 billion a year, given the increase in the number of people in developed countries with diabetes. The US market for diabetes medicines alone already exceeds $5 billion annually. AstraZeneca's shares were up 2% at $44.27 in midday trading.

Onglyza is indicated as a once-daily 5mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycemic control:

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