A drug originally approved to treat diabetes has gotten an expanded range of uses and is now available to treat heart failure more generally.
The U.S. Food and Drug Administration approved empagliflozin, also known by the brand name Jardiance, for a wider range of uses last week. The drug, initially approved in 2014 to treat type 2 diabetes, has gotten three more rounds of FDA approval since, all expanding the drug’s scope to treat heart disease.
The most recent approval authorizes Jardiance for use to “reduce the risk of cardiovascular death and hospitalization for heart failure in adults,” regardless of whether or not they suffer specifically from heart failure with reduced ejection fraction (HFrEF). Norman Stockbridge, MD, PhD, of the FDA’s Center for Drug Evaluation and Research said in a press release the treatment is now available to more patients with heart disease.
“While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure,” Stockbridge said in the statement.
Importantly, the drug was approved to reduce the risk of major outcomes (specifically death and hospitalization) from heart failure, not to prevent heart failure altogether. The drug was approved last summer to treat adults with HFrEF, its first approval for treatment of people who do not have diabetes.
Back in 2016, two years after its initial approval, Jardiance was authorized to treat heart failure in adults with type 2 diabetes. (The drug is strictly a type 2 diabetes drug and has never been approved or used to treat type 1 diabetes.) For this most recent approval, the drug was granted priority review status, the faster tier of FDA review reserved for treatments that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.”
Jardiance, developed and marketed by Germany’s Boehringer Ingelheim Pharmaceuticals and Indianapolis-based Eli Lilly and Company, was approved based on a series of studies known as the EMPEROR-reduced trials. The most recent of these projects, the Phase III study, wrapped up in the spring of 2021 and included almost 6,000 participants for 38 months. The study was done with a 10 mg pill, while the drug is also available in a 25 mg dosage.
Heart failure is defined by the Centers for Disease Control (CDC) as “when the heart cannot pump enough blood and oxygen to support other organs in your body.” The CDC reports that heart failure affects more than 6 million adults, and the FDA, in its most recent approval press release, writes the condition affects older adults more frequently and is the leading cause of hospitalization for those over 65.
HFrEF is a specific kind of heart failure, according to the University of Michigan, distinguished by the left ventricle pumping less than 40% of the normal amount of blood with each beat. A 2020 study published in the Journal of the American Medical Association suggests about half of worldwide heart failure cases are HFrEF.