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The U.S. Food and Drug Administration (FDA) on Thursday announced the approval of Jardiance to reduce the risk of death and hospitalization in adult patients with heart failure.
Originally approved in 2014 for improved glucose control in adults with type 2 diabetes, Jardiance is now “also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction,” the FDA said.
Jardiance (empagliflozin) is produced by Boehringer Ingelheim, a member of the Biotechnology Innovation Organization (BIO).
In a randomized, double-blind, international trial, 2,997 participants received 10-milligram doses of Jardiance once a day, and 2,991 participants received a placebo, according to the FDA. “Of the individuals who received Jardiance for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the placebo,” FDA said.
“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,” 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.
Due to the seriousness of the condition treated, Jardiance was subjected to priority review by the FDA.
