The FDA on Friday announced that it approved an expanded indication for Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) to include reducing the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease. Jean-Marc Guettier, director of the division of metabolism and endocrinology products at the FDA's Center for Drug Evaluation and Research, said the "availability of anti-diabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes."
The agency said its decision was backed by data from the post-marketing EMPA-REG OUTCOME trial, which demonstrated that Jardiance, in combination with standard of care, significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke versus placebo. In June, an FDA advisory panel voted by a margin of 12 to 11 that there was "substantial evidence" showing the SGLT-2 inhibitor reduces the risk of cardiovascular death, and also voted unanimously that the drug does not add to the risk of cardiovascular problems.
Commenting on the news, Evercore ISI analyst John Scotti said the expanded indication "arguably bodes well for the growth of the Jardiance franchise and for the SGLT-2 class as a whole," adding he expects Jardiance to garner sales of roughly $4 billion in 2025, with approximately $1.7 billion going to Eli Lilly. The SGLT-2 inhibitor class also includes Johnson & Johnson's Invokana (canagliflozin) and AstraZeneca's Farxiga (dapagliflozin), which the FDA approved in 2013 and 2014, respectively.
US regulators initially cleared Jardiance in 2014 to improve glycaemic control in adults with type 2 diabetes. The FDA had previously rejected the therapy due to issues at a Boehringer Ingelheim manufacturing facility in Germany, which were later resolved.
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