Eli Lilly, Boehringer's Heart Drug Jardiance Gets Priority Review from FDA
November 11 2021 - 2:37PM
Dow Jones News
By Kimberly Chin
Eli Lilly & Co. and Boehringer Ingelheim Pharmaceuticals
Inc. said Thursday that its heart drug Jardiance will be given
priority review by the U.S. Food and Drug Administration as a
potential treatment that could reduce the risk of cardiovascular
death and hospitalization for adults with heart failure regardless
of ejection fraction.
The FDA also accepted Eli Lilly and partner Boehringer's
supplemental new drug application for Jardiance.
Results from an advanced trial show that Jardiance was able to
reduce the relative risk of cardiovascular death or hospitalization
for heart failure in adults independent of left ventricular
ejection fraction--the amount of blood being pumped out of the
heart's left ventricle with each contraction.
In September, the FDA gave Jardiance a breakthrough therapy
designation for the treatment of adults with heart failure with
preserved ejection fraction. Jardiance has also received a
fast-track designation from the FDA.
Write to Kimberly Chin at kimberly.chin@wsj.com
(END) Dow Jones Newswires
November 11, 2021 14:22 ET (19:22 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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