EU regulators clear AstraZeneca, Bristol-Myers Squibb's combination diabetes therapy Xigduo

AstraZeneca and Bristol-Myers Squibb announced Wednesday that Xigduo (dapagliflozin/metformin) gained approval from the European Commission for the treatment of type 2 diabetes. The companies noted that the clearance is the first for a fixed-dose combination containing an SGLT2 inhibitor, in the form of Forxiga (dapagliflozin), and metformin.

Specifically, Xigduo is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control. AstraZeneca and Bristol-Myers Squibb said the therapy is indicated for patients who are inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of Forxiga and metformin as separate tablets. Shore Capital analyst Brian White said the approval of Xigduo, which was widely expected, will strengthen AstraZeneca's position in the "highly competitive market" for diabetes drugs.

Forxiga was approved in Europe in November 2012, and is currently authorised for the treatment of type 2 diabetes in 40 countries including Australia and the US, where it is sold as Farxiga. For related analysis, see Spotlight On: Why AstraZeneca's Farxiga approval is a win-win for Bristol-Myers Squibb and Physician Views Poll Results – Aggressive formulary placing key to Farxiga's success in US diabetes market despite anticipated strong growth for SGLT-2 inhibitor class.

In December last year, AstraZeneca entered an agreement to acquire Bristol-Myers Squibb's stake in the companies' diabetes joint venture for potentially as much as $4.3 billion, including an initial payment of $2.7 billion. The closing of the deal, which also includes up to $1.4 billion in regulatory, launch and sales-related payments to Bristol-Myers Squibb, is expected to occur during the first quarter.

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