Johnson & Johnson might just have a way to buoy its sinking Invokana sales. The diabetes drug put up data in chronic kidney disease patients showing it could stall progression and fend off cardiovascular problems, too, setting it up for a new FDA nod.
In a phase 3 study of Type 2 diabetes patients with chronic kidney disease, Invokana plus standard of care topped standard of care alone at delaying the disease’s progress. The SGLT2 drug also hit its marks on several cardiovascular outcomes, including cutting the risk of CV death and heart failure-related hospitalizations by 31%.
Kidney disease is a common complication of Type 2 diabetes, and poor kidney function can trigger heart failure and other serious CV problems. Holding kidney disease at bay represents a “huge advance” for patients, J&J exec James List said ahead of the data release.
The Credence win could help Invokana shore up its case after a boxed warning of lower-limb amputations took a big bite out of sales. The J&J drug suffered a 21% sales drop last year—and that’s on top of a similar decline in 2017, when the FDA added the label warning. All told, Invokana revenue fell to $881 million in 2018 from $1.4 billion in 2016, the company reported.
J&J stopped the Credence trial early last year when numbers turned up positive and filed those data with the FDA last month in hopes of adding the information to the drug’s official label. Rival drugs have yet to put up data from their own kidney outcomes studies.
Credence looked at Invokana plus standard of care—ACE inhibitors and angiotensin II receptor blockers—versus placebo and standard of care in 4,401 patients with Type 2 diabetes and chronic kidney disease over a median of 2.6 years. Invokana bested placebo by 30% in the study’s primary endpoint, a composite that covered progression to end-stage kidney disease; doubling of serum creatinine, a biomarker of kidney function; and death from kidney disease or cardiovascular problems.
Invokana held off heart problems, too, hitting three separate measures on the CV side. Patients on the SGLT2 drug were 20% less likely to suffer from major adverse cardio events and 39% less likely to be hospitalized for heart failure. The study didn’t show an imbalance in amputations or bone fractures, J&J reported.
J&J conducted the Credence study after previous studies turned up evidence of a benefit to kidney function. Other drugs in the SGLT2 class have similar hypotheses, but no confirming data as of yet, List said.
AstraZeneca has a kidney outcomes trial going on its SGLT2 drug, Farxiga, and Eli Lilly and Boehringer Ingelheim are putting their entry, Jardiance, through its paces in kidney disease patients, too.
List, who heads up Janssen’s cardiovascular and metabolic diseases business, said Type 2 diabetes is a “relentless” disease that affects all organ systems. One-third to one-half of Type 2 diabetes patients eventually get chronic kidney disease, the executive said in an interview. For many patients, renal function suffers over time and patients eventually progress to end-stage kidney disease.
“All together, these diseases really change patients’ lives and the lives of their families,” List said in an interview.
And that makes the Credence results “hugely significant” for patients, he said. There hasn’t been a new treatment to slow down kidney disease in nearly two decades, List pointed out, and with hundreds of millions of people suffering from Type 2 diabetes worldwide, an effective drug could have a big effect on “public health and human suffering.”
In the standard-of-care arm of the Credence study, 165 patients went on to develop end-stage kidney disease, versus 116 in the Invokana arm. Other patients died of kidney complications, while still others suffered heart attacks, strokes and other complications, List said. Invokana didn’t completely eliminate those complications, but showed statistically significant reductions in risks.