CV Risk Reduction Claim for Empagliflozin Filed With US FDA

January 25, 2016

Boehringer Ingelheim and Eli Lilly have filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME trial for their SGLT2 inhibitor empagliflozin (Jardiance) for the treatment of type 2 diabetes.

Cardiovascular complications can have a significant impact on the health and life expectancy of people with type 2 diabetes, and approximately 50% of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease, the companies say in their press release announcing that the FDA has accepted the sNDA.

Empagliflozin was first approved by the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes; it is also available in Europe.

In September 2015, the results of EMPA-REG were presented to much fanfare at the European Association for the Study of Diabetes (EASD) meeting in Stockholm; this was the first time that a diabetes drug offered cardiovascular benefits in addition to lowering blood glucose.

Empagliflozin showed a 38% relative risk reduction in cardiovascular mortality and a 32% risk reduction in all-cause mortality, compared with placebo, in the type 2 diabetes patients being studied, who had established cardiovascular disease and were already being treated with statins, ACE inhibitors, and aspirin.

"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," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals. "We look forward to working with the FDA as it reviews the data from the EMPA-REG OUTCOME trial."


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