European regulators have given the green light to AstraZeneca's diabetes combination Xigduo.
Xigduo combines Forxiga (dapagliflozin) with metformin in a twice-daily tablet and the European Commission thumbs-up represents the first regulatory approval for a fixed-dose combination of an SGLT2 inhibitor and metformin. Forxiga received marketing authorisation in Europe in November 2012 and bagged US approval earlier this month under the tradename Farxiga.
Elisabeth Bjork, head of late-phase cardiovascular and metabolic development at AstraZeneca, said that Xigduo "is an important addition to the range of medicines to help patients manage glycaemic control". She added that "not all patients are alike and…different treatments are needed, supporting a more personalised approach to disease management".
Dapagliflozin was co-developed with Bristol-Myers Squibb but last month AstraZeneca bought out the latter's stake in their diabetes joint venture for $2.7 billion upfront and regulatory- and sales-based milestone payments of up to $1.4 billion, plus royalties.