AstraZeneca and Bristol-Myers Squibb announced Wednesday that European regulators approved Forxiga (dapagliflozin) for the treatment of type 2 diabetes. The once-daily oral drug, which the companies noted is the first SGLT2 inhibitor to gain clearance for this indication, is approved for use in conjunction with diet modification and exercise either as a monotherapy in metformin-intolerant patients or in combination with other glucose-lowering medications.
In April, EU regulators recommended approval of the drug based on data from 11 late-stage studies involving 5693 patients with type 2 diabetes. In the trials, more patients receiving Forxiga achieved HbA1c goals than those taking placebo and the therapy was also associated with reductions in body weight and blood pressure.
Meanwhile, the FDA earlier this year issued a complete response letter requesting additional data on the companies’ application to market the therapy, after previously extending its review of the drug by three months. The decision followed an advisory panel's recommendation against approving Forxiga due to concerns about a potential risk of breast and bladder cancer, as well as possible liver and kidney risks, particularly among elderly patients. The companies are also currently seeking approval for Forxiga in other countries.
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