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ADA: J&J’s struggling Invokana slashes heart, kidney risks in latest trial win

J&J is awaiting a CKD approval for Invokana after receiving a priority review from the FDA. (Johnson & Johnson)

SAN FRANCISCO—Johnson & Johnson and its fellow SGLT2 drug makers are all working to show benefits for patients with kidney disease. But in that group, J&J can tout data its rivals don’t have.  

Tuesday at the American Diabetes Association annual meeting, J&J’s Janssen unit rolled out a new analysis from kidney outcomes trial Credence. The study showed Invokana could produce benefits across diabetic chronic kidney disease (CKD) patients with or without known cardiovascular disease.

“What we saw were very consistent findings both on the renal endpoints and on the cardiovascular endpoints in these patients,” said Jim List, Janssen’s cardiovascular and metabolism R&D head.

The findings make the latest subanalysis “perhaps the most intriguing or exciting” of the bunch, List said, pointing out that, “it’s the first time for an SGLT2 that there’s been some solid evidence of a cardiovascular benefit for patients without known cardiovascular disease.”

The new results follow April’s presentation of the Credence study, which showed that adding Invokana to standard-of-care therapy could delay the progress of kidney disease. Invokana also showed it could cut the risk of CV death and heart failure-related hospitalizations by 31% in diabetic CKD patients.

Based on those results, regulators in May granted the drug a priority review, setting it up for a new approval—and a chance for a sales boost its rivals don’t have—later this year. And Invokana, which has been hampered by amputation risks its rivals also don’t bear, could use a lift in the sales department after two straight years of declines.

While a CKD approval would be unique, Invokana isn’t the only member of the SGLT2 class to post positive kidney data at ADA. Sunday, AstraZeneca unveiled an analysis from cardiovascular outcomes study Declare showing that its contender, Farxiga, could trigger a 47% reduction in the combined risk of kidney function decline, end-stage renal disease and renal death in Type 2 diabetes patients.

And Eli Lilly and Boehringer Ingelheim, meanwhile, trumpeted a post-hoc analysis from the Empa-Reg Outcome study showing that Jardiance could reduce cardiovascular and renal risks in diabetic adults with cardiovascular disease and a form of chronic kidney disease without high protein levels in the urine.

But as List noted, “There’s only one completed kidney outcomes study in the SGLT2 class, and that’s Credence.”

Other analyses are “hypothesis-generating, but they don’t have the power or the right population” to show the effects that Invokana has demonstrated, he said, adding that “others going back into their databases and trying to find similar effects, I think, points to how important these findings are.”

That’s not to say AZ and the BI-Lilly team aren’t working to produce the same type of data J&J now has. AstraZeneca in 2016 launched a Phase IIIb study examining Farxiga in CKD, and BI and Lilly in 2017 announced plans to initiate a similar outcomes study for Jardiance.