Jardiance Snags Breakthrough Therapy for Heart Failure with Preserved Injection Fraction
Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.
Boehringer Ingelheim and Eli Lilly’s blockbuster diabetes drug Jardiance (empagliflozin) received Breakthrough Therapy designation from the FDA as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF).
Last fall, the FDA also granted Fast Track designation to the two pharma makers to develop a new heart attack-related indication for Jardiance.
Sales of the popular diabetes medication increased 36% to $356.5 million in the second quarter of 2021, per Zacks Investment Research.
The Breakthrough Therapy decision is based on results from the landmark EMPEROR-Preserved phase 3 trial, in which Jardiance demonstrated a 21% relative risk reduction for the composite primary end point of cardiovascular death or hospitalization for heart failure in adults with HFpEF compared with placebo, Boehringer Ingelheim and Lilly said in a news release.
HFpEF accounts for about half of the more than 6 million heart failure cases in the United States. No currently approved treatments have been clinically proven to significantly improve outcomes specifically for people with HFpEF, the pharma makers said.
Jeff Emmick, M.D., Ph.D.
"Given the scarcity of treatment options for this debilitating condition, the benefits demonstrated in the EMPEROR-Preserved trial constituted a major clinical breakthrough," Jeff Emmick, M.D., Ph.D., vice president of product development at Lilly, said in a statement. "Together with our Boehringer Ingelheim partners, we look forward to working closely with the FDA through this accelerated process to potentially bring Jardiance to adults with heart failure with preserved ejection fraction as soon as possible."
Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 on August 27 and were also published in The New England Journal of Medicine.
Newsletter
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
July 25th 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
July 24th 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
July 22nd 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More
