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7 Dec 2016

New Indication Approval: Jardiance received USFDA’s New Cardiovascular Indication approval

The US Food and Drug Administration (FDA) approved a new indication for Jardiance (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

Jardiance is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit.

Jardiance is marketed by Boehringer Ingelheim and Eli Lilly and Company. Under their diabetes collaboration, Lilly and Boehringer co-market several drugs across 17 countries, sharing costs and revenues. Lilly’s revenue from Jardiance is around $125 million in the first nine months of 2016.

In 2014, Jardiance was approved by the FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes.

Jardiance is not for people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).

The approval is based on breakthrough evidence from the landmark EMPA-REG OUTCOME trial

EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes and established cardiovascular disease.

The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

EMPA-REG OUTCOME trial investigated the effects of Jardiance compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. In the trial, Jardiance significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 per cent versus placebo (HR 0.86, 95% CI: 0.74-0.99); absolute risk reduction was 1.6 per cent for Jardiance versus placebo. This primary finding was driven by a significant 38 per cent reduction in the risk of cardiovascular death (HR 0.62, 95% CI: 0.49-0.77); absolute risk reduction was 2.2 per cent for patients taking Jardiance versus placebo. There was no change in the risk of non-fatal heart attack (HR 0.87, 95% CI: 0.70-1.09) or non-fatal stroke (HR 1.24, 95% CI: 0.92-1.67). The cardiovascular benefits of Jardiance were consistent among patient subgroups.

Adults with type 2 diabetes should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in Jardiance. Jardiance can cause dehydration and low blood pressure. Jardiance can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose when used with insulin or insulin secretagogues (e.g., sulfonylurea, a medication used to treat type 2 diabetes), vaginal yeast infections and yeast infections of the penis, and increased cholesterol.

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