FDA reviews Jardiance as cardiovascular diabetes treatment
pharmafile | January 27, 2016 | News story | Research and Development, Sales and Marketing | Boehringer Ingelheim, Eli Lilly, FDA, jardiance
The FDA has accepted Boehringer Ingelheim and Eli Lilly’s supplemental New Drug Application for their diabetes drug Jardiance to be used to help reduce the risk of cardiovascular death in patients with type 2 diabetes.
The companies are backing up the new application with data from the 7,000-patient EMPA-REG OUTCOME trial, which suggested a 38% reduction in the risk of cardiovascular death in patients treated with Jardiance (empagliflozin) – a drug they have developed as part of a multi-million dollar diabetes collaboration signed in 2011.
“We’re proud of this acceptance as we are now one step closer to helping address one of the most prevalent clinical needs of the type 2 diabetes community – reducing the risk of cardiovascular death,” says Paul Fonteyne, president and chief executive of Boehringer Ingelheim Pharmaceuticals. “We look forward to working with the FDA as it reviews the data from the EMPA-REG OUTCOME trial.”
Cardiovascular complications can have a significant impact on the health and life expectancy of people with type 2 diabetes. Approximately half of deaths in people with the type 2 form of the disease worldwide are caused by cardiovascular disease.
Jardiance 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, but it is not indicated for type 1 diabetes or for people with diabetic ketoacidosis.
Approximately 29 million Americans and an estimated 415 million people worldwide have type 1 or type 2 diabetes; nearly 28% of American diabetics are undiagnosed; and some 12% of the US population aged 20 and older have diabetes. Type 2 diabetes accounts between 90 and 95% of all diagnosed cases there.
Joel Levy
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