FDA accepts supplemental application for Jardiance

The FDA accepted a supplemental New Drug Application for the SGLT2 inhibitor Jardiance, following cardiovascular risk reduction data reported in the landmark EMPA-REG trial, Boehringer Ingelheim and Eli Lilly and Company announced in a press release.

In a statement, the two companies noted they expect to receive a decision from the FDA within the standard review time frame.

“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,” Paul R. Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc., said in a press release. “We look forward to working with the FDA as it reviews the data from the EMPA-REG Outcome trial.”

In announcing the findings from the EMPA-REG Outcome trial, a randomized, double-blind, placebo-controlled trial in 42 countries, researchers said that Jardiance (empagliflozin, Boehringer Ingelheim), when combined with standard care, 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 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 drug is not intended for patients with type 1 diabetes or for people with diabetic ketoacidosis.