FDA’s approval of a new indication for empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) could net the pharmaceutical manufacturers more than $1 billion.
Thanks to the new indication-Jardiance can be prescribed to reduce the risk of cardiovascular disease in adults with type 2 diabetes and cardiovascular disease-Eli Lilly could gain as much as $1.7 billion in revenue by 2025, according to Evercore analyst John Scotti, StockMarketDailyreported.
The cardiovascular indication is important because deaths due to cardiovascular disease are 70% higher in patients with diabetes compared to those without diabetes, according to the Centers for Disease Control and Prevention. Plus, diabetics have a decreased life expectancy driven in large part by premature cardiovascular death.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “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.”
FDA’s decision is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
In the clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease, empagliflozin significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo, according to Eli Lilly. This primary finding was driven by a significant 38% reduction in the risk of cardiovascular death and an absolute risk reduction was 2.2% for patients taking empagliflozin versus placebo.
The most common side effects of empagliflozin are urinary tract infections and female genital infections. Jardiance is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. The drug is also contraindicated in patients with a history of serious hypersensitivity reactions to empagliflozin, severe renal impairment, end-stage renal disease or dialysis.
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