AstraZeneca reported successful results from the company’s Phase III DAPA-CKD clinical trial of Farxiga (dapagliflozin) in end-stage kidney disease.
The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) for the treatment of heart failure in adults with reduced ejection fraction.
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.
Independent experts on an FDA advisory panel voted against the use of an already approved drug from Eli Lilly and Boehringer Ingelheim as an add-on to insulin therapy for type 1 diabetes.
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.
AstraZeneca’s Farxiga was granted fast track designation by U.S. regulators for the treatment of heart failure, boosting prospects of wider use of the diabetes drug and putting the medicine ahead of rivals.
The U.S. Food and Drug Administration granted fast track status for the development of AstraZeneca’s diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
Shares of Texas-based Lexicon Pharmaceuticals shot up after the company announced positive 52-week cardiorenal data from a pooled analysis of the type 1 diabetes trials Tandem1 and Tandem2.
Janssen’s Invokana became the only medicine in nearly 20 years and the first diabetes medicine ever to demonstrate a reduction in progression to end-stage renal failure in T2D patients with CKD.