AstraZeneca's blockbuster Farxiga secures landmark approval in heart failure patients, regardless of whether they have diabetes
Last October, the FDA cleared the use of AstraZeneca’s blockbuster therapy Farxiga to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or CV risk factors. Now, the US agency has opened up the use of the diabetes drug in an even bigger population: to reduce the risk of CV death and hospitalization for heart failure in all patients, even those that don’t have diabetes.
Patients with diabetes are often afflicted with other comorbidities, such as obesity, CV disease, and kidney problems. SGLT2 drug makers have been clamoring for a broader market share by differentiating their drugs on the basis of therapeutic impact on these intersecting indications — but the major, most lucrative battleground is the heart.
In September, AstraZeneca unveiled data from the DAPA-HF trial, which showed the drug cut the risk of CV death or the worsening of heart failure in patients with heart disease. The 4,744-patient trial tested Farxiga in patients (with and without type 2 diabetes) with reduced ejection fraction — in which the heart muscle is not able to contract amply and, therefore, expels less oxygen-rich blood into the body — in addition to standard-of-care treatment.
“The ground-breaking results of the DAPA-HF trial have transformed heart failure therapeutics. Today’s approval provides physicians with a completely novel pharmacological approach that greatly improves outcomes for patients with heart failure with reduced ejection fraction,” said John McMurray from the Institute of Cardiovascular and Medical Sciences, University of Glasgow, in a statement.
Farxiga reduced the composite endpoint of cardiovascular (CV) death or worsening of heart failure by 26% (p<0.0001) — including a reduction in each of the individual components of the endpoint. Data showed there was a 30% decrease (p<0.0001) in the risk of experiencing a first episode of worsening heart failure and an 18% cut (p=0.0294) in the risk of death from cardiovascular causes.
Farxiga, akin to Invokana from J&J $JNJ and Jardiance from Eli Lilly $LLY, belongs to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination. Although the class of drugs is united by similarities, Invokana’s label is crippled with the risk of amputation, unlike Jardiance and Farxiga.
Farxiga was initially approved for use in type 2 diabetes back in 2014 — it generated more than $1.5 billion in sales last year.
In late March, the British drugmaker wrapped up a late-stage study testing the drug in a chronic kidney disease population after registering “overwhelming efficacy” in patients, regardless of type 2 diabetes status — in the United States alone, that’s a market of roughly 30 million patients. With the explosion of coronavirus cases across the globe, the company is also testing Farxiga as a potential therapy to reduce organ failure in Covid-19 patients.