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FDA Accepts Cardiovascular Outcomes Data for Diabetes Drug Empagliflozin (Jardiance)
The FDA has accepted a supplemental new drug application for empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) based on cardiovascular (CV) risk-reduction data from the landmark EMPA-REG OUTCOME trial. A decision from the FDA is expected within the standard review time frame.
Cardiovascular complications can have a significant effect on the health and life expectancy of people with type-2 diabetes. Approximately 50% of deaths in people with type-2 diabetes worldwide are caused by cardiovascular disease.
Empagliflozin was approved by the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes. The treatment is not indicated for people with type-1 diabetes or for people with diabetic ketoacidosis.
The EMPA-REG OUTCOME trial was a long-term, randomized, double-blind, placebo-controlled study involving more than 7,000 patients with type-2 diabetes at high risk for cardiovascular events. The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care consisted of glucose-lowering agents and CV drugs (including those for blood pressure and cholesterol). The study’s primary endpoint was the time to first occurrence of CV death, nonfatal heart attack, or nonfatal stroke.
Over a median period of 3.1 years, empagliflozin significantly reduced the risk of CV death, nonfatal heart attack, or nonfatal stroke by 14% compared with placebo. The risk of CV death was reduced by 38%, with no significant difference in the risk of nonfatal heart attack or nonfatal stroke. Treatment with empagliflozin also resulted in a 32% reduction in all-cause mortality and a 35% reduction in hospitalization for heart failure.
Source: Lilly; January 25, 2016.