SAN DIEGO—There’s officially another heart-helping SGLT2 on the block. But this one brings some varied benefits—and amputation risks—along with it.
In a cardiovascular outcomes trial, Johnson & Johnson's Invokana matched up to Eli Lilly and Boehringer Ingelheim's Jardiance at cutting a composite measure of CV risks, posting a 14% reduction. Those paying close attention may recognize that 14% is the same mark Jardiance hit back in 2015.
But that’s where the similarities between the two data sets end. Unlike Jardiance, which failed to make a significant difference in the risk of heart attack or stroke, Invokana pared down risks in both measures—by 15% and 10%, respectively.
On the flip side, though, while J&J’s entrant was able to slash the risk of cardiovascular death by 13%, that number pales in comparison with Jardiance's 38%—a figure that now has a place on the Lilly/BI med's label.
J&J's pleased with the Invokana data, unveiled on Monday at the American Diabetes Association's annual meeting, and the company will be looking for a label update on its drug, too.
“We think, looking at the data—the size, the breadth, the duration of the trials—we think these are very strong, very clinically important, and we look forward to filing this with FDA and other regulatory agencies around the world,” Jim List, Janssen’s global therapeutic head for cardiovascular and metabolism, said in an interview ahead of the release.
One more stat stood out for Invokana, too, however—and that was “about a twofold increase” in the rate of lower extremity amputations, List said. That risk first came to light in 2016 when it was flagged by an independent data monitoring committee, and the FDA said in May of this year that it would require new warnings—including a black box, its most serious—to be added to the med's label.
List was quick to point out, though, that the hazard ratio seemed to “hold true regardless of a patient’s background”—meaning that despite the doubling, “patients at a very low risk of amputations remain at a very low risk of amputations,” he said.
Still, within the SGLT2 class, it’s a risk that’s unique to Invokana—as far as investigators currently know.
“The amputation imbalance is a headwind for JNJ in particular,” Evercore ISI analyst Umer Raffat wrote in a Monday note to clients.
Meanwhile, J&J highlighted the potential kidney benefits investigators saw during the trial; results showed that the med cut the risk of “clinically important renal outcomes,” including renal death and kidney replacement, by 40%. And the way J&J sees it, that figure “could be quite predictive of what we will see in the Credence trial,” an ongoing outcomes study specifically looking at Invokana’s effects on the kidney.