Escalate Life Sciences
With trial success in kidney disease, Lilly, Boehringer make case for broader use of diabetes drug
Eli Lilly and Boehringer Ingelheim's drug Jardiance kept clinical trial participants with kidney disease from needing dialysis or a transplant, the companies announced Wednesday, a finding that cements the diabetes pill's potential as a treatment for a wider array of metabolic diseases.
The trial was expected to deliver results near the end of 2022, when at least half of the patients had been on treatment for three years. But Jardiance's positive effects were so strong that clinical trial monitors advised the companies to stop testing early, according to the statement.
The announcement is a sign that Jardiance's use could soon broaden once again. First approved as a blood sugar-lowering treatment in 2014, Jardiance was in the past year also cleared for heart failure patients. The Food and Drug Administration is currently evaluating its use in kidney disease.
Jardiance's widening potential has followed doctors' growing understanding of the commonalities between diabetes, heart disease, high blood pressure and kidney disease. Drugs in Jardiance's class, which treat diabetes by helping the body excrete blood sugar, also appear to reduce pressure on the heart and within the kidneys. Those effects may explain why the drugs, known as SGLT2 inhibitors, are useful for people with renal problems.
Boehringer, working with Lilly and a division of the University of Oxford, began testing that theory in 2019 by enrolling the first of 6,600 patients in a study known as EMPA-KIDNEY. Trial volunteers had kidney disease resulting from a wide variety of causes, including diabetes, and had both mild and severe symptoms. They were randomized to take either Jardiance or a placebo and followed to measure whether Jardiance could delay the need for dialysis, a kidney transplant or death from cardiovascular causes.
Lilly didn't release specific results, stating it would outline them at an upcoming medical meeting. Physicians will closely examine the data when it's available, particularly for evidence of how well Jardiance works in patients without diabetes.
If Jardiance is approved in kidney disease, it will follow AstraZeneca's rival diabetes pill Farxiga, which the FDA cleared last April. A third drug in this class, Johnson & Johnson's Invokana, is also marketed for prevention of kidney failure, but only in type 2 diabetics.
Although Jardiance isn't yet authorized to treat as many diseases as Farxiga, it is still the biggest-selling drug in the class. Lilly recorded $1.5 billion in Jardiance revenue and Boehringer 2.5 billion euros ($2.7 billion) in 2021, compared with a total of $3 billion for Farxiga and $563 million for Invokana over the same time period.
Published March 16, 2022
Jonathan Gardner, Senior Reporter
Original Source https://www.biopharmadive.com/news/jardiance-kidney-disease-trial-lilly-boehringer/620473/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-03-17%20BioPharma%20Dive%20%5Bissue:40448%5D&utm_term=BioPharma%20Dive