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AZ gets green light in EU for Xigduo diabetes combination

Wins approval for first line extension of Forxiga

AZ BMSAstraZeneca's run of positive news continues, with the company securing EU approval for Xigduo, the first line extension for its highly-anticipated new diabetes drug Forxiga.

Xigduo combines the active ingredient in Forxiga - the SGLT2 inhibitor dapagliflozin - with diabetes therapy stalwart metformin in a twice-daily, oral tablet that is indicated for use in adults with type 2 diabetes.

EU approval has been given to AZ and Bristol-Myers Squibb (BMS), although AZ will assume complete control over Xigduo when its $4.3bn buyout of the two companies' five-year-old diabetes alliance goes through later this quarter.

Dapagliflozin was the first SGLT2 inhibitor to be approved for marketing when the EMA cleared it in 2012, and the drug was also approved in the US as Farxiga earlier this month. It competes with Johnson & Johnson's Invokana (canagliflozin), which won the race to the US market after the FDA delayed dapagliflozin's approval.

Xigduo is the first combination of an SGLT2 inhibitor and metformin to be registered and, according to AZ's head of late-phase cardiovascular and metabolic development Elisabeth Björk, is "an important addition to the range of medicines to help patients manage glycaemic control".

"We recognise that not all patients are alike and that different treatments are needed, supporting a more personalised approach to disease management," she added.

Meanwhile, J&J's combination canagliflozin and metformin product has been held up by the FDA after the agency raised questions about its dosing, specifically whether the canagliflozin component in the twice-daily combination acts the same as the once-daily formulation of the drug.

Dapagliflozin has had a fairly slow start in the market in Europe, mainly because of reimbursement issues which have resulted in AZ and BMS threatening to withdraw the drug from the German market, but the recent US approval and launch of Xigduo could lend some momentum to the franchise.

J&J reported its 2013 results yesterday, and while it did not break out Invokana sales since its launch in the second quarter of that year did suggest the product was a key growth driver, contributing 2 points to its US revenue growth rate and capturing 19 per cent of new-to-brand prescriptions (NBRX) in the non-insulin diabetes segment.

Article by
Phil Taylor

22nd January 2014

From: Sales



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