The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) for the treatment of heart failure in adults with reduced ejection fraction.
New data from a sub-analysis of the landmark Phase III DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) trial showed that AstraZeneca’s Farxiga (dapagliflozin) reduced the incidence of the primary composite endpoint of heart failure worsening or cardiovascular death compared to placebo, in patients with heart failure with reduced ejection fraction, irrespective of their background therapy.
Three months after winning FDA approval in type 2 diabetes, AstraZeneca is eyeing a potential U.S. regulatory win for Farxiga as a treatment in heart failure patients.
Merck & Co. Inc.’s experimental treatment vericiguat being developed with Bayer AG for patients with worsening chronic heart failure met the main goal of a late-stage study.
AstraZeneca announced new data from five additional analyses of the landmark Phase III DAPA-HF trial, which showed that Farxiga (dapagliflozin) reduced the risk of the primary composite outcome of worsening heart failure or death from cardiovascular causes versus placebo, when added to standard of care.
Cyclerion Therapeutics announced the failure of two separate clinical trials for the same drug on the same day.
AstraZeneca’s blockbuster drug Farxiga won U.S. approval as a treatment to reduce the chances of hospitalization for heart failure in adults with type 2 diabetes and other cardiovascular risks.
Invokana won U.S. approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
A landmark French trial will seek to settle one of the country’s biggest pharmaceutical scandals, probing whether the company behind a weight-loss drug believed to have triggered killer side effects covered up the risks.
Novartis announced results from two new clinical trials evaluating improvement in heart structure and function and long-term safety of Entresto in patients with heart failure with reduced ejection fraction (HFrEF).