FDA grants fast-track status to Eli Lilly, Boehringer Ingelheim's SGLT2 inhibitor Jardiance for use in chronic heart failure

Eli Lilly and Boehringer Ingelheim said Wednesday that the FDA has granted a fast-track designation to Jardiance (empagliflozin) for use in decreasing the risk of cardiovascular death and hospitalisation for heart failure in patients suffering from chronic heart failure. According to the companies, the designation is for the ongoing EMPEROR programme, which includes the EMPEROR-Reduced and EMPEROR-Preserved studies evaluating the effect of the once-daily SGLT2 inhibitor on cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction, respectively.

"Heart failure contributes to one in nine deaths and is a leading cause of hospitalisation in the US, yet there are limited treatment options," remarked Mohamed Eid, vice president of clinical development and medical affairs at Boehringer Ingelheim, adding that the fast-track designation for Jardiance is an "important step forward in addressing this unmet need."

EMPEROR-Reduced will enroll approximately 3600 patients, while EMPEROR-Preserved will involve about 5250 patients. The placebo-controlled trials include patients with and without diabetes who are receiving current standard of care. Both studies, scheduled to be completed next year, will assess time to first event of adjudicated cardiovascular death or adjudicated hospitalisation for heart failure for a period up to 38 months.

Jardiance is already approved in the US to treat adults with type 2 diabetes, and has also been cleared to lower the risk of cardiovascular death in type 2 diabetes patients with cardiovascular disease.

Boehringer Ingelheim recorded sales of €1.5 billion ($1.7 billion) for Jardiance in 2018, while Eli Lilly posted first-quarter revenues of $203.6 million for the treatment.

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