- The Food and Drug Administration approved expanded use of Eli Lilly and Boehringer Ingleheim's diabetes drug Jardiance, announcing Thursday that the pill can be used in a broader group of heart failure patients. The FDA cleared the drug for sicker patients, those with weaker heart muscles, in August 2021.
- The FDA's decision was based on a large trial testing Jardiance against a placebo over more than two years in about 6,000 heart failure patients. Jardiance reduced the risk of hospitalization for heart failure complications or cardiovascular death by about one-fifth.
- The latest FDA approval means Jardiance can be used in a group of patients that numbers about 3 million in the U.S., giving Lilly and Boehringer an advantage over rival AstraZeneca. While the U.K. drugmaker's diabetes pill Farxiga was the first approved for treat heart failure, its trial in healthier patients hasn't yet read out results.
First approved as blood sugar-lowering drugs for people with diabetes, Jardiance and Farxiga have proven beneficial in treating heart failure, too, regardless of whether patients are diabetic.
This class of drugs, which also includes Johnson & Johnson's Invokana, work in diabetes by helping patients excrete glucose through urine. Why they work in heart failure, even in the absence of diabetes, isn't completely clear, although scientists hypothesize the benefit may come from reductions in blood pressure or fluid that affects the heart.
AstraZeneca was first to make inroads in heart failure, which is classified by how much blood patients' hearts can pump. Farxiga won approval in May 2020 for people with heart failure whose hearts can pump less than 40% of the volume in their left ventricles — a diagnosis that represents about half of all patients. Jardiance won a similar clearance more than a year later.
In the other half of patients, those with "preserved ejection fraction," however, AstraZeneca will now have to catch-up to Lilly and Boehringer. Its trial in that set of patients is due to read out before July, and the company expects to ask the FDA and other regulators for approval in the second half of 2022. Assuming normal review timelines, AstraZeneca might be a year behind Lilly and Boehringer in launching Farxiga for preserved ejection fraction.
The two drugs are close competitors commercially. AstraZeneca reported $3 billion in Farxiga sales in 2021, while Eli Lilly's portion of Jardiance revenue totaled $1.5 billion. Boehringer, a privately held company, hasn't released 2021 figures yet, but through the first half of the year reported 1.4 billion euros ($1.6 billion) in Jardiance revenue.