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FDA approves expanded indication for empagliflozin to reduce CV death in type 2 diabetes
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The FDA approved a new indication for the SGLT2 inhibitor empagliflozin to reduce the risk for cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease, the FDA announced in a press release.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” Jean-Marc Guettier, MD, CM, director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research, said in a statement. “Availability of antidiabetes 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 expanded indication comes 1 year after results from the landmark EMPA-REG OUTCOME trial, a randomized, double blind, placebo-controlled trial conducted in 42 countries with more than 7,000 patients. The postmarketing study, which was required by the FDA when the drug was first approved in 2014, found that empagliflozin (Jardiance, Boehringer Ingelheim) reduced the risk for CV death by 38% compared with placebo, with no significant difference in the risk for nonfatal myocardial infarction or stroke. Patients treated with empagliflozin also experienced a 32% reduction in all-cause mortality risk and a 35% reduction in risk for hospitalization for heart failure, according to researchers.
Empagliflozin can cause dehydration and hypotension, as well as diabetic ketoacidosis, serious urinary tract infection, acute kidney injury, and impairment in renal function and hypoglycemia when used with insulin or sulfonylureas. Other possible adverse events include vaginal yeast infections, genital mycotic infections and increased cholesterol.
Empagliflozin is not intended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, and is not indicated for use in patients with severe renal impairment, end-stage renal disease, or dialysis.
“Approximately two out of three people with type 2 diabetes still die from cardiovascular disease,” Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, Inc., said in a statement. “This new indication represents a tremendous step forward in our efforts to reduce the impact of cardiovascular disease among adults with type 2 diabetes and established cardiovascular disease. We believe that this medicine is an important new treatment option for this patient population.
Disclosure: Fonteyne is an employee of Boehringer Ingelheim Pharmaceuticals, Inc. Guettier is an employee of the FDA.