Dive Brief:
- Eli Lilly presented data Nov. 13 showing that Jardiance (empagliflozin) consistently reduced the risk for cardiovascular death, compared with placebo, when added to standard of care in adults who have type 2 diabetes and established cardiovascular disease.
- The findings, presented at the American Heart Association (AHA) Scientific Sessions 2016, stem from analysis of a large, long-term cardiovascular outcomes trial, dubbed EMPA-REG, supported by Boehringer Ingelheim and Eli Lilly.
- After a three-month delay, the U.S. Food and Drug Administration is expected to announce Dec. 4 whether Jardiance can label itself as having cardiovascular benefit.
Dive Insight:
"Cardiovascular disease is two to four times more common in people with type 2 diabetes... Since approximately two out of three deaths in people with type 2 diabetes in the U.S. are attributed to cardiovascular causes, we need diabetes therapies that help reduce this complication in individuals who have an underlying cardiovascular issue,” said the trial's lead investigator, Bernard Zinman, director of Diabetes Centre at Mount Sinai Hospital in Toronto.
Most of the data on Jardiance, the first drug in its class to show cardio-protective abilities, were announced previously. But Eli Lilly's presentation of findings at the key AHA event came days before the FDA's decision on product labeling for new indications, which, if favorable, would give it a competitive edge in a crowded market.
This is especially true since outcomes trials includes a large number of patients and often take years to complete. EMPA-REG looked at 7,000-plus patients from 42 countries with type 2 diabetes and established cardiovascular disease, finding that over a median of 3.1 years, Jardiance reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo; risk of cardiovascular death fell by 38%.
In a third-quarter earnings call, Eli Lilly said it anticipates that by gaining the new cardiovascular friendly indication for Jardiance from the FDA, the company's combination medication Glyxambi, which pairs Jardiance's active ingredient, empagliflozin, with the DPP-4 antagoinst Tradjenta (linagliptin), can ride on Jardiance's coattails.
Yet the FDA's decision on new cardio-benefit labeling for Jardiance isn't a given. In June, an FDA advisory panel approved the idea on a narrow 12-11 split and some analysts have described Lilly as having "coin-flip odds" of success.