FDA to Review Data on Jardiance CV Benefits
Boehringer Ingelheim and Eli Lilly announced that the Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME trial.
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled study evaluating Jardiance (10mg or 25mg once daily) added to standard of care vs. placebo added to standard care in more than 7,000 patients with type 2 diabetes (T2D) at high risk for cardiovascular (CV) events. Standard of care therapy included glucose-lowering agents, antihypertensives, and anti-cholesterol drugs. The primary endpoint was time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.
Data from the study showed that Jardiance reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14% vs. placebo over a median of 3.1 years. Risk of CV death was reduced by 38%, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. In addition, a 32% reduction in all-cause mortality and a 35% reduction in hospitalization for heart failure were seen in patients treated with Jardiance.
Jardiance, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.