Eli Lilly’s Jardiance scores expanded heart failure approval from the FDA and will now be available to all patients with heart failure to reduce the risk of death and hospitalization.
Photo courtesy of Michael Vi
One of Eli Lilly’s diabetes drugs just scored another win with the U.S. Food and Drug Administration to expand its use in the heart failure population.
Jardience will now be available to all patients with heart failure to reduce the risk of death and hospitalization. The FDA first approved the Boehringer Ingelheim-partnered drug in 2014 for patients with type 2 diabetes. Two years later, it added another indication for reducing cardiovascular death in adults with T2D. It snagged approval for adults living with heart failure with reduced ejection fraction just last fall.
The diabetes and heart failure drug is already sixth on Lilly’s list for drug revenue, pulling in nearly $1.5 billion last year. While that number earns it blockbuster status, it’s still lagging pretty far behind Lilly’s top diabetes drug. Trulicity sported close to $6.5 billion in revenue for 2021.
Jardiance also faces stiff competition from AstraZeneca’s Farxiga, also approved for T2D and some heart failure patients, and last year added approval to treat chronic kidney disease patients as well. Farxiga doubled the 2021 revenues of Jardiance.
With diabetes and cardiovascular disease in the top four list of non-communicable diseases worldwide, the market for this drug just got a lot bigger. The CDC estimates the patient applicable population at about 6.2 million people.
The latest approval is based on a nearly 6,000-participant trial, with half receiving 10 mg of Jardiance daily and the other half taking a placebo. The main measurements were time to death from a cardiovascular cause or the need to be hospitalized for heart failure. The most significant benefit was seen in fewer patients hospitalized for heart failure. Over 1 million Americans are hospitalized each year with the condition.
Heart failure is often accompanied by the loss of kidney function, resulting in chronic kidney failure (CKD). This trial also showed Jardiance’s potential to slow kidney function decline. Keeping up with the competition, aka Farxiga, Eli Lilly is likely planning to push Jardiance for CKD approval next.
“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research.
“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. Coinciding with February’s annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease.”
