FDA to Review Data on Jardiance CV Benefits

Data from the study showed that Jardiance reduced the risk of CV death
Data from the study showed that Jardiance reduced the risk of CV death

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.

RELATED: New Type 2 Diabetes Management Algorithm Released 

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.

For more information visit Boehringer-ingelheim.com or Lilly.com.

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