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(Source:Archive)

Days after US regulators granted a swift review for Jardiance for another chronic heart failure indication, Boehringer Ingelheim GmbH and Eli Lilly and Company have presented data showing that their blockbuster SGLT2 inhibitor could benefit adults hospitalized with acute heart failure.

The partners have presented data from the 530-patient Phase III EMPULSE trial at the American Heart Association meeting which revealed that adults treated with Jardiance (empagliflozin, 10mg/day for 90 days) were 36% more likely to experience a clinical benefit compared with placebo. Those benefits were reduced all-cause mortality (Jardiance 4.2% vs 8.3% placebo), fewer heart failure events (10.6% versus 14.7%) and an improvement in symptoms compared with participants who received placebo.

Heart failure is classified as acute when patients experience fluid build-up in the lungs and requires urgent treatment and hospitalization. Once released, these patients are at a greater risk of death, re-hospitalization and a lower quality of life.

Researchers acknowledged that a limitation to the study was its relatively small sample size but lead author Adriaan Voors of the University Medical Centre Groningen in the Netherlands, noted that EMPULSE "is the first time we have really seen this type of medication work so effectively and safely in patients who were hospitalized for acute heart failure, regardless of heart failure history or diabetes status." He added that these results "may lead to earlier and more frequent treatment with empagliflozin, which may improve the lives of more people with heart failure.”

Voors said that even though there are a number of drugs available to improve clinical outcomes in patients with chronic heart failure, like Jardiance, AstraZeneca PLC's rival SGLT2 inhibitor Forxiga/Farxiga (dapagliflozin) and Novartis AG's Entresto (sacubitril/valsartan), "very few medicines have proven to benefit patients with new, acute onset of heart failure needing hospitalization.” He pointed out that no increase in serious adverse events effects was seen for the patients on Jardiance compared with placebo.

The EMPULSE results add to the stream of good clinical, regulatory and commercial news that Jardiance has been enjoying of late. Last week, the US Food and Drug Administration accepted Boehringer and Lilly's supplemental new drug application and granted a priority review for the drug, which bagged its first US approval back in 2014 for type 2 diabetes, as a potential treatment to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction (LVEF); in June and August respectively, the European Medicines Agency and the FDA approved Jardiance for heart failure patients with reduced ejection fraction (HFrEF). (BILillys Jardiance Takes On AstraZenecas Farxiga With Heart Failure Approval) (BILillys Jardiance Enters US Heart Failure Market Fray)

The sNDA is based on results from the potentially game-changing EMPEROR-Preserved Phase III trial, in which Jardiance was associated with a 21% reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with LVEF over 40% compared with placebo. Those results, presented at the European Society of Cardiology in August, were independent of ejection fraction or diabetes status and if the FDA gives the green light, Jardiance would be the first clinically proven treatment for adults across the full spectrum of heart failure regardless of ejection fraction.

Also, in a new sub-analysis of EMPEROR-Preserved presented earlier this month at the American Society of Nephrology Kidney Week, Jardiance reduced the risk of cardiovascular death and hospitalization for heart failure, while slowing kidney function decline in adults with LVEF over 40% regardless of chronic kidney disease status at baseline. Nearly half of adults with heart failure also have CKD and the EMPA-KIDNEY study is evaluating the effects of Jardiance on the progression of renal disease and cardiovascular death, with results due in 2022.

Sales-wise, the drug is performing strongly. In the third quarter, Lilly noted that its share of Jardiance revenues reached $390.4m, an increase of 26% compared with the like, year-earlier period.

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