US Food and Drug Administration (FDA) Advisory Committee voted 12-11 that substantial evidence exists to establish that Jardiance (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. Jardiance, which is marketed by Boehringer Ingelheim and Eli Lilly and Company, is the only oral T2D medicine shown in a clinical trial to reduce the risk of CV death.
"Today's robust discussion and resulting vote are important as we look to gain approval of a new indication for Jardiance as the first type 2 diabetes treatment to provide a cardiovascular benefit," said Thomas Seck, M.D., vice president, clinical development and medical affairs - metabolism, Boehringer Ingelheim Pharmaceutical, Inc. "We look forward to continuing to work with the FDA in our ongoing efforts to provide options that help reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease."
The recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the landmark EMPA-REG OUTCOME trial, which found that Jardiance significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in adults with T2D and established CV disease. The primary finding was driven by a 38 per cent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of Jardiance was consistent with that of previous trials.
"Despite significant advances in the prevention and treatment of cardiovascular disease over the past several decades, more than half of adults with type 2 diabetes worldwide still die due to cardiovascular causes," said Jeff Emmick, M.D., Ph.D., vice president, product development, Lilly Diabetes. "The cardioprotective profile of Jardiance could provide an additional option to physicians to reduce the risk of cardiovascular death in their patients with type 2 diabetes."
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with T2D and established CV disease.
The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.
Over a median of 3.1 years, Jardiance significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 per cent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
The overall safety profile of Jardiance in the EMPA-REG OUTCOME trial was consistent with that of previous trials.