FDA Advisory Committee recommends approval of Jardiance for cardiovascular indication

Endocrinologic and Metabolic Drugs Advisory Committee votes in favour of cardiovascular mortality benefit for JARDIANCE for adults with type 2 diabetes.

"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 CV benefit," said Thomas Seck, 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 CV death in adults with type 2 diabetes and established CV 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% when added to standard of care in adults with T2D and established CV disease. The 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.

"Despite significant advances in the prevention and treatment of CV disease over the past several decades, more than half of adults with type 2 diabetes worldwide still die due to CV causes," said Jeff Emmick, vice president, product development, Lilly Diabetes. "The cardioprotective profile of Jardiance could provide an additional option to physicians to reduce the risk of CV death in their patients with type 2 diabetes."