FDA OKs new indication for Jardiance

Jardiance is now FDA approved to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction.
Levy

The Food and Drug Administration has given the green light to Boehringer Ingelheim and Eli Lilly for a new indication for Jardiance.

The medication is now approved to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction. 

Jardiance can be initiated in adults with HFrEF with an eGFR as low as 20 mL/min/1.73 m2.

[Read more: Boehringer Ingelheim's Lilly's Jardiance gets new indication]

"Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical," said Javed Butler, chairman, of the Department of Medicine, University of Mississippi. "Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalization for adults with heart failure with reduced ejection fraction."

HFrEF, which accounts for more than half of heart failure cases, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.

[Read more: FDA gives Lupin tentative nod for generic Jardiance]

Jardiance already is approved to lower blood sugar along with diet and exercise in adults with Type 2 diabetes; and to reduce the risk of cardiovascular death in adults with Type 2 diabetes who also have known cardiovascular disease; and reduce the risk of cardiovascular death and hospitalization for heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) in adults with heart failure.

[Read more: Boehringer Ingelheim names Yew Looi Liew president of U.S. human pharma]

 

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