AstraZeneca announced Wednesday that the FDA has approved Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults suffering from heart failure with reduced ejection fraction (HFrEF), regardless of whether they have type 2 diabetes. The company noted that the drug is the first SGLT2 inhibitor approved in the US to treat patients with HFrEF.
Last October, the FDA cleared Farxiga to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes and established CV disease or multiple CV risk factors. The product is also indicated to improve glycaemic control in adults with type 2 diabetes. Ruud Dobber, president of AstraZeneca's BioPharmaceuticals business unit, said of the latest approval that "we expect, especially the cardiologist, to embrace this new treatment option for the non-diabetic patients."
The FDA decision was based on results from the Phase III DAPA-HF trial, which showed that adding Farxiga to standard of care cut the risk of the composite outcome of CV death or worsening of heart failure by a significant 26% versus placebo in patients with HFrEF (for related analysis, see ViewPoints: AstraZeneca lays out game plan for capitalising on DAPA-HF). AstraZeneca also noted that during the trial, one CV death or hospitalisation for HF, or an urgent visit associated with HF, could be avoided for every 21 patients treated with Farxiga.
Mene Pangalos, who heads R&D at the BioPharmaceuticals unit, remarked "we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with [HFrEF] in the US." Analysts are forecasting Farxiga sales of almost $3 billion in 2024, up from $1.5 billion last year. AstraZeneca recently said the drug brought in $407 million in the first quarter, up 16% from the year-ago period, tied to growth in Europe and emerging markets.
Eli Lilly and Boehringer Ingelheim are also testing the benefits of their SGLT2 inhibitor Jardiance (empagliflozin) in heart failure patients with or without diabetes, but Dobber noted these programmes were about six months to eight months behind. In November, the companies said an interim analysis of three-year data from the EMPRISE real-world study showed Jardiance was associated with a decreased risk of hospitalisation for heart failure and a similar risk of non-fatal atherosclerotic CV events compared with DPP-4 inhibitors and GLP-1 receptor agonists.
Meanwhile, in March, AstraZeneca halted the Phase III DAPA-CKD trial ahead of schedule after Farxiga showed "overwhelming efficacy" at slowing chronic kidney disease in patients, irrespective of the presence of type 2 diabetes. At the time, the company said it would start discussions with global health authorities regarding early regulatory submissions for the SGLT2 inhibitor in this indication.
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