AstraZeneca's SGLT2 diabetes med Farxiga is chugging ahead to a pioneering FDA approval in heart failure patents with or without Type 2 diabetes—a first in its class. As it awaits that nod, Farxiga has shown it can also be effective in treating heart failure patients regardless of other therapies they are receiving.
Farxiga reduced the risk of heart failure worsening or death over placebo in heart failure patients regardless of other therapies received during the trial, according to data released Saturday at the American College of Cardiology scientific sessions.
In the Dapa-HF outcomes trial, heart failure with reduced ejection fraction (HFrEF) patients had been treated with a broad range of other pharmaceuticals, device therapies and cardiac resynchronization therapies, AstraZeneca said. Irrespective of those other therapies, Farxiga showed a "consistent reduction" in its targeted CV outcomes across the board.
"By reducing the risk of heart failure worsening regardless of background therapy, Farxiga has the potential to improve current standard of care and reduce the burden of disease for heart failure patients across the globe," Mene Pangalos, AstraZeneca’s executive vice president of biopharmaceuticals R&D, said in a release.
The new subanalysis from Dapa-HF could boost prescriptions for Farxiga in HFrEF, where the drug has already scored an FDA nod for patients who also have Type 2 diabetes. Meanwhile, the FDA is also reviewing the drug to treat heart failure patients with or without Type 2 diabetes—a potentially game-changing indication for the SGLT2 diabetes-fighting class on the whole.
In January, the FDA granted Farxiga a priority review in that first-of-its-kind indication based on Dapa-HF data showing the drug cut CV risks by 26% when added to standard-of-care therapy for heart failure patients with or without Type 2 diabetes.
In that study, Farxiga cut the combined risk of cardiovascular death or hospitalization in HFrEF. The FDA’s expedited review covered Farxiga’s pursuit of indications in both HFrEF and heart failure with preserved ejection fraction (HFpEF) patients, AstraZeneca said.
If Farxiga scores that much-desired FDA approval, it would give AstraZeneca a major leg up over its SGLT2 rivals in a heart failure market that could increase sevenfold from $3.7 billion in 2018 to $22.1 billion in 2028, according to GlobalData.
Meanwhile, one Farxiga challenger––Eli Lilly and Boehringer Ingelheim's Jardiance––recently flopped its own trial in heart failure patients with or without diabetes.
In December, Jardiance failed to improve exercise ability over placebo in chronic heart failure patients with or without diabetes, according to top-line data from two phase 3 studies, Emperial-Reduced and Emperial-Preserved.
The two studies treated patients with Jardiance or a dummy pill for 12 weeks and judged exercise ability using a six-minute walk tests, Boehringer said in a release. Despite the loss, Boehringer is still looking forward to other trials in its Jardiance heart failure program.