A diabetes drug jointly marketed by Eli Lilly (NYSE: LLY) and German pharmaceutical company Boehringer Ingelheim has won FDA approval expanding its use to include reducing the risk of cardiovascular death in diabetes patients.
The FDA initially approved empagliflozin (Jardiance) in 2014 as a way to improve blood sugar control, in addition to diet and exercise, in adults who have type 2 diabetes. Eli Lilly’s stock price perked up 2.64 percent on news of the cardiovascular approval of the drug Friday, closing at $67.71 per share.
Empagliflozin is one of several drugs in global pact between Eli Lilly and Boehringer Ingelheim to develop and commercialize new diabetes treatments. The once-daily pill is part of a class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors. It works by blocking the kidney from reabsorbing glucose, allowing it to instead be excreted in urine, thus lowering blood glucose levels in patients who have type 2 diabetes. Other SGLT2 inhibitors include Johnson & Johnson’s (NYSE: JNJ) canagliflozin (Invokana) and AstraZeneca’s (NYSE: AZN) dapagliflozin (Farxiga). According to an ISI Evercore research note cited by Reuters, expanded use of empagliflozin could bring sales of the drug to $4 billion in 2025; $1.7 billion of that revenue going to Eli Lilly.
Patients who have diabetes often also have heart problems, which can increase the risk of dangerous complications. The risk of death from cardiovascular disease is 70 percent higher in adults who have diabetes compared to those who don’t have the disease, according to the Centers for Disease Control and Prevention. Eli Lilly and Boehringer Ingelheim studied empagliflozin in a postmarket study that was required as part of the initial approval. The study enrolled 7,000 patients who have both type 2 diabetes and cardiovascular disease.
The companies said that over the course of the clinical trial, the diabetes drug reduced the risk of cardiovascular death by 38 percent. The trial showed no significant difference in the risk of heart attack or stroke. Eli Lilly and Boehringer Ingelheim said the safety profile of the drug in the cardiovascular disease trial was consistent with results seen in previous trials. Last June, an advisory committee to the FDA narrowly voted to recommend approval of the drug in the cardiovascular indication.
The FDA notes that empagliflozin can cause dehydration and low blood pressure, as well as ketoacidosis, a buildup of acids in the blood from high blood sugar. The most common side effects of the drug are urinary tract infections and female genital infections.