The FDA announced Wednesday the approval of AstraZeneca and Bristol-Myers Squibb's Farxiga (dapaglifozin) to improve glycaemic control, along with diet and exercise, in adults with type 2 diabetes. An agency advisory panel voted to recommend approval of the SGLT2 inhibitor in December after the agency previously rejected the therapy in 2012 on concerns of its potential risks of bladder and breast cancers.
The regulator said that the therapy’s safety and effectiveness was evaluated in 16 clinical trials of more than 9400 patients with type 2 diabetes, with Farxiga being linked to improvements in HbA1c levels. However the FDA also noted that the drug was associated with an increased number of bladder cancers in clinical testing.
As part of the approval, the FDA is requiring six post-marketing studies, including a cardiovascular outcomes trial to evaluate the cardiovascular risk of the therapy in patients at risk of cardiovascular disease and a study to assess the bladder cancer risk of patients enrolled in the outcomes trial. The agency is additionally requiring two studies to evaluate the pharmacokinetics, efficacy and safety of the drug in paediatric patients, as well as an enhanced pharmacovigilance program to examine reports of liver abnormalities and pregnancy outcomes.
Morningstar analyst Damien Conover remarked that the SGLT2 class is under-appreciated by investors and that drugs such as Farxiga could take market share from older therapies. "We're big believers in [the] SGLT2 class," commented Conover, who predicted that the therapy could reach $1.5 billion in revenue by 2018. The medicine was authorised in Europe in 2012, where it is marketed under the name Forxiga.
AstraZeneca recently announced that it will acquire the entirety of Bristol-Myers Squibb’s interests in the drugmakers' diabetes joint venture to consolidate worldwide ownership of the diabetes business within AstraZeneca, with the transaction expected to close during the first quarter of 2014.
For related analysis, read In Focus: With a second AdCom imminent – will US approval of Forxiga be a bittersweet victory for AstraZeneca and Bristol-Myers Squibb? and ViewPoints: AstraZeneca acquires Bristol-Myers Squibb diabetes JV – three key conclusions.
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