EASD: Lilly, BI tout new Jardiance kidney analysis as rival J&J nears FDA nod

Eli Lilly and Boehringer Ingelheim's new analysis comes from the Empa-Reg outcomes trial. (Boehringer Ingelheim)

BARCELONA—Eli Lilly and Boehringer Ingelheim, eager to keep pace with rivals, are out with new Jardiance kidney disease data in a patient population they say mirrors the one that could soon score Johnson & Johnson’s Invokana a new nod.

Tuesday at the European Association for the Study of Diabetes annual meeting, the partners presented results showing Jardiance’s positive effects on cardiovascular and kidney outcomes were consistent whether or not patients had advanced kidney disease.

RELATED: ADA: Lilly, BI's Jardiance cut kidney disease progression in Empa-Reg analysis

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The data come from the Empa-Reg Outcome trial, the first study ever to show a diabetes drug could improve cardiovascular outcomes. Since then, the pharma partners have mined the trial for all sorts of insights to gauge the treatment’s effects on various groups of patients.

This time around, the companies wanted to “look at patients within Empa-Reg who were more like the patients” in Johnson & Johnson’s Invokana kidney outcomes trial—and some that weren't, said Jyothis George, BI’s head of medicine for Jardiance.

In that study, dubbed Credence, “patients had a lot of proteinuria,” or protein leaking from the kidney, and the drug produced a benefit among those patients. But “the clinical question here is, 'do we have to wait for that degree of kidney damage to see a benefit?'” George said.

And the latest results say no. Lilly and BI looked at patients both with and without proteinuria and saw consistent effects from Jardiance across both groups. In other words, “you don’t have to wait for complications to come—you might as well use” Jardiance “early and see benefits,” George said, adding that “we believe we have the breadth of data to support earlier use rather than later use.”

RELATED: Invokana win in kidney patients could help J&J right the SGLT2 ship

BI and Lilly are hoping doctors agree as they look to boost sales of the SGLT2 contender. Despite snagging first-in-class status for a heart-helping indication on Jardiance’s label, the drug doesn’t have a big lead when it comes to sales. Its 2018 total of €1.46 billion ($1.61 billion) only narrowly topped the $1.39 billion haul from AstraZeneca’s Farxiga, which doesn’t even yet have a CV nod to its name.

Once-blockbuster Invokana, meanwhile, has seen sales steadily drop over the last two years, thanks to a boxed warning outlining its increased risk of lower-limb amputations. But the company is hoping that a kidney boost—expected from the FDA this year after a May priority review designation—can help get sales pumping.

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