– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction
– FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine”[i],[ii]
– Heart failure represents a significant, growing disease burden in the U.S., with more than 8 million cases expected by 2030
The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.
Jardiance is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR below 30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action.
Jardiance can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m2.
“In its phase III trials, empagliflozin has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction,” said Javed Butler, M.D., chairman, Department of Medicine, University of Mississippi. “Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options.”
Affecting more than 6 million people in the U.S., heart failure is a leading cause of hospitalization and is becoming increasingly prevalent due to the aging population. Just six months ago, Jardiance was approved to reduce the risk of cardiovascular death plus hospitalization for one type of heart failure – heart failure with reduced left ventricular ejection fraction (LVEF). Today’s decision expands this indication to adults with heart failure. As a result, the indication now includes adults with preserved LVEF.
This approval is based on results from the landmark EMPEROR-Preserved® phase III trial, which investigated the effect of Jardiance 10 mg compared with placebo once daily, both on top of standard of care therapy, in 5,988 adults with heart failure with LVEF over 40%. In the trial, Jardiance demonstrated a 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure. In both EMPEROR-Preserved® and EMPEROR-Reduced®, the benefit was generally consistent across LVEF subgroups.
“The EMPEROR-Preserved trial demonstrated breakthrough benefits for a widely underserved group of people who have heart failure. With today’s news, Jardiance becomes the first and only heart failure treatment to show a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure in adults with heart failure, regardless of ejection fraction,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “This approval, with a decision for use in the EU by the European Commission expected to follow, represents an important milestone in our efforts to redefine heart failure care and advance treatment options for people with a range of cardio-renal-metabolic conditions.”
“This approval reinforces the potential of Jardiance as a crucial treatment option to help fill an urgent need for adults across the full spectrum of heart failure,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “Building on the indication for heart failure with reduced ejection fraction last year, this decision marks the third U.S. FDA approval for Jardiance stemming from the EMPOWER program and adds to a growing legacy of leadership for the Boehringer Ingelheim and Lilly Alliance spanning cardiovascular disease and type 2 diabetes.”
About EMPEROR-Preserved
EMPEROR-Preserved (NCT03057951) was a phase III international, randomized, double–blind trial that enrolled 5,988 adults with and without type 2 diabetes. All participants had heart failure (New York Heart Association [NYHA] functional class II, III or IV) and LVEF over 40%; 4,005 (67%) had HFpEF (LVEF of at least 50%), and 1,983 (33%) had mildly reduced LVEF (greater than 40% but less than 50%).
What is JARDIANCE?
JARDIANCE is a prescription medicine used to:
reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body
reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease
lower blood sugar along with diet and exercise in adults with type 2 diabetes
JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).
JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work.About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
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