USA – The FDA announced that Jardiance (empagliflozin) by Eli Lilly and Boehringer Ingelheim has been approved to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure (HF) in adults, regardless of ejection fraction.

The FDA approved the Sodium-glucose transport protein 2 (SGLT2) inhibitor in 2014 to help adults with type 2 diabetes control their glucose levels.

Its label has since been expanded to include lowering the risk of CV death in adults with type 2 diabetes and established CV disease.

Last year, the FDA approved the drug for lowering the risk of death and hospitalization in patients with Heart failure with reduced ejection fraction (HFrEF).

The approval was based on the Phase III EMPEROR-Reduced trial, which demonstrated that when added to standard of care, it reduced the primary outcome of first hospitalization for HF or CVD-related death by 25%, regardless of diabetes status.

Norman Stockbridge, director of the division of cardiology and nephrology in the FDA’s Center for Drug Evaluation and Research, said the decision “will provide a treatment option for a wider range of patients with HF.”

Jardiance’s approval gives it an advantage in the highly competitive heart failure market, where AstraZeneca’s Farxiga, Novartis’ Entresto, and Merck and Bayer’s Verquvo are already competing for market share.

Heart failure is a syndrome in which the heart does not meet the needs of the body, and it affects over 650,000 people in the United States each year.

Despite multiple drug classes, mortality remains high, and treatment options for a broader range of patients are required.

Shortness of breath, fatigue, and swelling in the legs are some of the symptoms of heart failure.

Heart failure becomes more common as people get older and is the leading cause of hospitalization in people over the age of 65.

Merck and Bayer’s Verquvo received FDA approval in January to treat high-risk HFrEF patients.

In the same space, Novartis received a broader US label for its drug Entresto (sacubitril/valsartan) last year, which included lowering the risk of CV death and heart failure hospitalizations in adults with chronic heart failure.

In 2020, the FDA expanded the list of indications for AstraZeneca’s Farxiga (dapagliflozin), which, like Jardiance, blocks SGLT2, to include reducing the risk of CV death and HF hospitalizations in adult HFrEF patients, regardless of diabetes status.

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