Lilly, Boehringer's Jardiance bags FDA approval for heart failure

The FDA has expanded the label for Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) to include reducing the risk of cardiovascular death plus hospitalisation for heart failure (HF) in adult patients with reduced ejection fraction (HFrEF), the companies announced Wednesday. The decision follows EU approval granted in June for the same indication.

The FDA filing was backed by results from the Phase III EMPEROR-Reduced trial showing that Jardiance led to a significant 25% relative risk reduction on a composite of cardiovascular death or hospitalisations for HF, regardless of baseline HF medications or type 2 diabetes status, when added to standard of care. Moreover, the rate kidney function decline, as measure by estimated glomerular filtration rate (eGFR), was slower with Jardiance than with placebo, when both were given on top of standard treatments. The companies said Jardiance can be initiated in HFrEF patients with an eGFR as low as 20 mL/min/1.73 m2.

The SGLT2 inhibitor "is already a recognised leader for adults with type 2 diabetes, including those who also have established cardiovascular disease," remarked Jeff Emmick, head of product development at Eli Lilly. He noted that "following EMPA-REG OUTCOME, this is the second US regulatory decision stemming from the EMPOWER clinical trial programme…exploring the impact of Jardiance on major clinical cardiovascular outcomes." The drugmaker said Jardiance brought in sales of $356.5 million in the second quarter, up 36% from the year-ago period, and beating forecasts by $25 million.

Filings in HFpEF expected this year

Last month, Eli Lilly and Boehringer Ingelheim reported top-line results from the Phase III EMPEROR-Preserved study in which Jardiance significantly cut the risk of cardiovascular death or HF-related hospitalisations compared to placebo in chronic HF patients with preserved ejection fraction (HFpEF). The companies have said regulatory submissions for Jardiance in this indication are forthcoming this year (for related analysis, see KOL Views Q&A: Leading expert says Jardiance win in HFpEF suggests SGLT-2s will battle for slices of expanding pie).

In February, Novartis was granted a broader US label for Entresto (sacubitril/valsartan) to include reducing the risk of cardiovascular death and HF hospitalisations in adults with chronic HF, making it the first drug approved for both HFrEF and HFpEF. Meanwhile, AstraZeneca's Farxiga (dapagliflozin), which like Jardiance also blocks SGLT2, saw its list of indications expanded by the FDA last year to include reducing the risk of cardiovascular death and HF hospitalisations in adult HFrEF patients, regardless of diabetes status.

Have a look at this recent Physician Views poll we conducted that suggests Jardiance's performance in the EMPEROR-Preserved study could position the drug as a competitive threat to Entresto.