Nearly three years after Eli Lilly and Boehringer Ingelheim reported that Jardiance cut cardiovascular risks in a landmark outcomes trial named Empa-Reg, the study is still producing info about the drug. Now, based off a post-hoc analysis, investigators report that Jardiance cut the risk of kidney disease progression in the trial.
In data presented at the American Diabetes Association's annual meeting, investigators reported that Jardiance lowered the risk of new or worsening kidney disease versus placebo independent of control of CV risk factors.
"In this analysis, the reduced risk of kidney disease progression seen with Jardiance was present whether or not patients had control of common cardiovascular risk factors, such as cholesterol and blood pressure," BI's Thomas Seck, VP of clinical development and medical affairs, said in a statement.
It's good news for the companies as they plan to test their drug in the disease area. After seeing the Empa-Reg data, the partners last year said they would run an outcomes trial assessing Jardiance in kidney disease patients, both with and without diabetes. If successful, the companies could seek a FDA label expansion for Jardiance.
The partners reported their landmark Empa-Reg results back in 2015 and have since won an FDA label expansion detailing Jardiance's ability to help diabetes patients cut cardiovascular risks. J&J's rival Invokana has also posted data showing it can cut CV risks, but CV outcomes study data for that drug included a significantly higher amputation risk for patients. Now, J&J is seeking the CV label addition for Invokana.
At ADA this weekend, J&J presented data from a real-world analysis showing Invokana didn't raise the risk of amputation in patients above SGLT2 rivals or other diabetes drugs.
According to a recent note from Evercore ISI analyst Josh Schimmer detailing prescription data, Jardiance led Invokana in total SGLT2 prescriptions as of April, with AstraZeneca's Farxiga trailing. Merck and Pfizer have a newer entrant in the class called Steglatro.