- Eli Lilly and partner Boehringer Ingelheim on Wednesday said the Food and Drug Administration has approved their diabetes drug Jardiance to treat patients with a specific type of heart failure.
- Doctors can now prescribe the medication for heart failure patients with reduced ejection fraction, which happens when an enlarged heart muscle fails to contract properly and pumps less blood than needed into the body. It's a common form of heart failure, which overall affects more than 6 million Americans, according to the Centers for Disease Control and Prevention.
- The FDA cleared the new use based on the companies' EMPEROR-Reduced study, which found treatment with Jardiance reduced the risk of cardiovascular death and hospitalization by 25% compared with a placebo. Researchers included patients with and without Type 2 diabetes and saw benefits for both groups.
The expanded approval offers a significant boost for Jardiance, sales of which are already on track to top $1 billion this year. In the second quarter, revenue from the drug jumped 36% to about $357 million.
Lilly and Boehringer next have their eyes on approval for heart failure patients with preserved ejection fraction. The harder-to-treat condition occurs when the left ventricle can't properly relax, resulting in the heart being unable to fill with enough blood to pump out to the body even though it's still contracting normally.
Jardiance is the first medicine shown to reduce cardiovascular death and hospitalization for preserved ejection fraction patients in a late-stage study, according to Lilly. The company announced positive results from the trial in July, saying Jardiance showed a significant benefit, but didn't give details. Researchers plan to present results at the European Society of Cardiology meeting later this month.
If the detailed data are as promising as Lilly claims, Jardiance could become a widely used treatment for heart failure. Until an approval for Novartis' Entresto in February, no drug was cleared for both reduced and preserved ejection fraction patients. Novartis won approval despite a trial that failed to meet its primary goal of significantly reducing heart failure hospitalizations and deaths.
Meanwhile, AstraZeneca is on the same path as Lilly and Boehringer, testing its diabetes drug Farxiga in patients with preserved ejection fraction. That study is due to finish in January. The British drugmaker won an approval for Farxiga in reduced ejection fraction patients last May.