(Reuters) – The U.S. Food and Drug Administration approved AstraZeneca Plc’s diabetes drug to reduce the risk of cardiovascular death and hospitalisation for heart failure in certain patients, the drugmaker said on Wednesday.
The FDA approval was based on positive results from a late-stage trial in which the drug, Farxiga, achieved a statistically significant reduction in cardiovascular deaths or hospitalisation for heart failure, compared with placebo.
The approval comes just weeks after the British drugmaker said it was testing Farxiga as a potential treatment for COVID-19 patients, who also had existing heart and kidney problems.
Farxiga, approved as a treatment for type-2 diabetes, is part of the SGLT2-inhibitor class of antidiabetic medication that causes the kidneys to expel blood sugar through urine and has shown promise in various heart and kidney condition trials.
Heart failure is a life-threatening disease in which the heart cannot pump enough blood around the body, and it affects about 64 million people worldwide.
Farxiga, which is among AstraZeneca’s top five drugs by sales, is also being tested as a potential treatment for patients with chronic kidney disease.
(Reporting by Aakash Jagadeesh Babu in Bengaluru, Editing by Sherry Jacob-Phillips)
