FDA Panel Votes in Favor of Empagliflozin for CV Death Reduction

The Committee voted 12–11 in favor of approval
The Committee voted 12–11 in favor of approval

The Food and Drug Administration (FDA)'s Endocrinologic and Metabolic Drug Advisory Committee voted 12–11 that substantial evidence exists to support Jardiance (empagliflozin; Boehringer Ingelheim and Lilly) for the reduction of cardiovascular (CV) death in adults with type 2 diabetes and established CV disease. 

The recommendation for approval was based on data from the long-term, multicenter, randomized, double-blind, placebo-controlled EMPA-REG OUTCOME trial (n>7,000) that evaluated the effect of Jardiance 10mg or 25mg once daily added to standard of care vs. placebo added to standard of care. The primary endpoint was the time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.

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The data showed Jardiance significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14% over a median of 3.1 years when added to the standard of care vs. placebo. There was a 38% reduction in CV death with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The safety profile of Jardiance was consistent with that of previous studies.

Jeff Emmick, MD, PhD, of Lilly Diabetes, stated, "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." 

Jardiance, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is available as 10mg and 25mg strength tablets.

For more information call (800) 243-0127 or visit Jardiance.com.

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