AstraZeneca PLC said the U.S. Food and Drug Administration approved Farxiga to cut the risk of hospitalization for heart failure in certain patients with type 2 diabetes.
Farxiga, or dapagliflozin, can now be used by adult patients with type 2 diabetes and established cardiovascular disease or multiple heart-related risk factors to reduce the risk of hospitalization for heart failure.
The approval is based on data from a late-stage study called Declare-Timi 58, in which Farxiga was shown to reduce the likelihood of hospitalization for heart failure or heart-related death, the Cambridge, U.K.-based drugmaker said.
Taking Farxiga cut hospitalizations for heart failure by 36% in patients with a reduced ejection fraction — a measure of how much blood the heart pumps out with each contraction. For those without reduced ejection fraction, the drop in hospitalizations was 24%.
In August, the European Commission approved a label update for Farxiga — marketed in the EU as Forxiga — expanding the medicine's marketing authorization to include positive cardiovascular outcomes. Farxiga is being evaluated by Chinese regulators, with a decision expected in the first half of 2020.
Farxiga belongs to a class of drugs known as SGLT-2 inhibitors — along with Johnson & Johnson's Invokana and Boehringer Ingelheim GmbH's Jardiance — and is approved to improve glycemic control in adults with type 2 diabetes. This class of therapies, also known as gliflozin drugs, works by absorbing glucose via the kidneys so that excess glucose is passed out of the body via urination.