AstraZeneca PLC said Farxiga will undergo an expedited review process in the U.S. for reducing the risk, or worsening, of heart conditions in certain patients.
The U.S. Food and Drug Administration accepted AstraZeneca's supplemental new drug application and granted priority review to Farxiga, or dapagliflozin, to lessen the risk of cardiovascular death or the worsening of heart failure in adults with reduced ejection fraction, with or without type 2 diabetes.
Heart failure affects about 64 million individuals globally, at least half of which have a reduced ejection fraction, which happens when the heart's left ventricle is not pumping as well as normal.
The FDA is to complete its review by the second quarter of the year.
Cambridge, U.K.-based AstraZeneca's application was based on the results of a landmark phase 3 study dubbed DAPA-HF, which showed Farxiga significantly cut the risk of heart-related sudden death or worsening of disease in certain heart failure patients.
In September 2019, the FDA granted fast-track designation for the development of Farxiga in two types of heart failure. In August of that year, Farxiga received fast-track status from the FDA to help delay the progression of renal failure.
Farxiga, which is marketed as Forxiga in the EU, is indicated as a single therapy and as part of combination therapies to improve blood sugar levels in adults with type 2 diabetes. Farxiga is also approved in the U.S. to cut the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple heart-related risk factors.