Health and Healthcare

Eli Lilly Rises on Positive FDA Committee Vote

Chris Lange

Published: June 29, 2016 11:47 am

Last Updated: January 13, 2020 6:14 am

Eli Lilly and Co. (NYSE: LLY) is watching its shares make a decent gain on Wednesday following a U.S. Food and Drug Administration (FDA) vote. The 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.

Keep in mind that Jardiance, which is marketed by Boehringer Ingelheim and Eli Lilly, is the only oral T2D medicine shown in a clinical trial to reduce the risk of CV death.

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% when added to standard of care in adults with T2D and established CV disease.

This primary finding was driven by a 38% 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.

Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs – Metabolism, Boehringer Ingelheim Pharmaceutical, commented:

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. 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.

Jeff Emmick, M.D., Ph.D., vice president, product development, Lilly Diabetes, added:

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. 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.

Shares of Eli Lilly were last trading up 3.5% at $77.73, with a consensus analyst price target of $95.71 and a 52-week trading range of $67.88 to $92.85.