FDA grants fast track designation to empagliflozin for treatment of chronic heart failure
The FDA has granted fast track designation for the SGLT2 inhibitor empagliflozin for the reduction of risk for cardiovascular death and hospitalization for heart failure in people with chronic heart failure, according to a press release from Boehringer Ingelheim and Eli Lilly and Co.
Fast track is a designation of an investigational drug for expedited review to facilitate the development of drugs that treat a serious or life-threatening condition and fill an unmet medical need, according to the FDA. The designation must be requested by the drug company.
The designation is for the ongoing EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will evaluate the effect of empagliflozin (Jardiance) on CV death and hospitalization for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction, respectively.
“Heart failure contributes to 1 in 9 deaths and is a leading cause of hospitalization in the U.S., yet there are limited treatment options for people living with this debilitating disease,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs at Boehringer Ingelheim, said in the release. “The FDA fast track designation for empagliflozin is an important step forward in addressing this unmet need, and we look forward to working closely with the FDA as we explore the potential for empagliflozin to improve outcomes for adults with chronic heart failure.”
The two EMPEROR phase 3 studies include more than 8,500 people with chronic heart failure and are designed to assess the effect of treatment with empagliflozin on CV death and hospitalization for chronic heart failure as primary endpoints. EMPEROR-Preserved is designed to investigate the safety and efficacy of empagliflozin in approximately 5,250 patients with chronic heart failure with preserved ejection fraction for up to 38 months, with an estimated completion by 2020. EMPEROR-Reduced is designed to investigate the safety and efficacy of empagliflozin in approximately 3,600 patients with chronic heart failure with reduced ejection fraction for up to 38 months, also with an estimated completion by 2020.
Results from EMPA-REG, first presented in September 2015 and reported by Endocrine Today, showed that empagliflozin 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. The study included more than 7,000 adults with type 2 diabetes, BMI of 45 kg/m² or less, HbA1c between 7% and 10% and an established history of CV disease (mean age, 63 years; 72% men; mean HbA1c, 8%; mean BMI, 30.6 kg/m²)
In an actuarial analysis of the EMPA-REG Outcome trial published in Circulation in October, researchers found that adults with type 2 diabetes and established CVD who take empagliflozin can expect to live between 1 and 5 years longer than those without the drug, depending on the person’s age when initiating treatment.
“Boehringer Ingelheim and Lilly are committed to advancing treatments that address the public health challenges of cardiometabolic diseases, including chronic heart failure,” Jeffrey Emmick, MD, PhD, vice president of product development at Lilly, said in the release. “We eagerly anticipate results from the EMPEROR studies as we advance the development of empagliflozin in this setting.” – by Regina Schaffer
Disclosures: Eid is vice president of clinical development and medical affairs at Boehringer Ingelheim. Emmick is vice president of product development at Lilly.