An AstraZeneca diabetes drug that brought in more than $1.5 billion in sales last year has won an FDA nod expanding its use to adults with systolic heart failure, a condition in which the heart struggles to pump with enough force to push enough blood into circulation.
The drug, the once-daily pill dapagliflozin (Farxiga), was approved late Tuesday for adults with heart failure whose ejection fraction—a measurement of how much blood the left ventricle can pump with each contraction—is below 40 percent. Those patients’ ejection fraction is considered “reduced” compared to the normal range, which is 50 percent to 70 percent.
Dapagliflozin is part of a class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors, which promote the reabsorption of glucose by the body and its excretion in urine as a method of lowering patients’ blood sugar levels.
Nearly a decade ago SGLT2 inhibitors were somewhat of a lost cause. An FDA advisory panel voted against dapagliflozin in 2011 when AstraZeneca (NYSE: AZN) and New York-based Bristol-Myers Squibb (NYSE: BMY), with which it developed the drug, submitted it for approval. In January 2012 the agency rejected it entirely. But two years later the drug received an FDA nod for patients with type 2 diabetes to use to better control their blood sugar levels, in addition to diet and exercise.
Last October it was OK’d to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and heart health risks. Now the drug has become the first SGLT2 inhibitor approved to treat adults with heart failure with reduced ejection fraction.
Dapagliflozin was studied in more than 4,700 patients, who were randomly assigned to receive a 10-milligram dose of the drug daily or a placebo. After about 18 months, people who received the drug had fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those receiving the placebo, according to the company. Patients whose condition is limiting their physical activity, as determined by a classification system doctors use to categorize heart failure according to symptom severity, are eligible to take the new AstraZeneca treatment.
The AstraZeneca drug joins other SGLT2 inhibitors on the market for cardiovascular indications, such as empagliflozin (Jardiance), a diabetes drug jointly marketed by Eli Lilly (NYSE: LLY) and German pharmaceutical company Boehringer Ingelheim. In 2016, that drug won FDA approval expanding its use to include reducing the risk of cardiovascular death in diabetes patients. In 2019 Lilly’s revenue from the drug totaled $944.2 million.
Heart failure is just one of the indications into which the British drug maker is seeking label expansion for dapagliflozin. In the second half of the year, the company plans to ask regulators to evaluate it as a treatment for chronic kidney disease.
The company has also looked to convince regulators to approve its use for blood sugar control, in conjunction with insulin, for adults with type 1 diabetes, but the FDA last year rejected AstraZeneca’s submission. The drug has been approved for type 1 diabetes patients by regulators in the EU and Japan.
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