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FDA clears BMS/AZ's dapagliflozin at second attempt

Diabetes drug approved as companies look to end alliance
FDA headquarters White Oak

AstraZeneca (AZ) and Bristol-Myers Squibb (BMS) have finally won FDA approval for their diabetes drug dapagliflozin in the US, although BMS will shortly cede its rights to the drug.

The US regulator gave the go-ahead for dapagliflozin - which will be sold in the US as Farxiga - to improve glycaemic control in adults with type 2 diabetes, although it has asked for half a dozen post-marketing studies of the drug.

Dapagliflozin was rejected by the FDA in 2012 amid concerns that it may be linked to an increased risk of bladder and breast cancers.

An FDA advisory committee concluded that the benefits of the drug outweighed its risks towards the end of last year, although the FDA has asked for a number of studies to examine the drug's effect on cardiovascular outcomes, as well as cancer risks, as a condition for approval.

Dapagliflozin has been available in Europe since 2012, when it became the first compound in the new SGLT2 inhibitor class to reach the market under the name Forxiga. The delays in the US meant that Johnson & Johnson was able to overtake AZ and BMS at the final hurdle and launch its rival drug Invokana (canagliflozin) in 2013.

Forxiga has had a slow uptake in Europe thanks to difficulties securing pricing and reimbursement agreements with national health systems, despite a positive reaction to the new drug from physicians, according to AZ and BMS. The two firms have threatened to withdraw the drug altogether in Germany after pricing negotiations reached an impasse, and AZ will be hoping that approval in the US will help kickstart sales growth.

If that occurs AZ will reap the benefit, having reached a $4.3bn deal to acquire outright ownership of the diabetes assets it co-developed with BMS last December, bringing a five-year-old alliance to a close and adding almost $1bn to its revenues.

The handover is scheduled to complete in the first quarter of 2014 and - if analyst predictions of peak sales of $1.5bn or more a year for Farxiga turn out to be valid - the deal looks like good value for AZ.

In a recent presentation to analysts, AZ said it expects global sales of drugs used to treat diabetes to reach around $60bn in 2018, noting that a little under half of that total will come from newer classes such as SGLT2 inhibitors, DPP-4 inhibitors like its Onglyza (saxagliptin) product and GLP-1 agonists. AZ will also have a commanding position in the latter category following the alliance's $7bn acquisition of Amylin in 2012.

9th January 2014

From: Sales

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