Johnson & Johnson said the U.S. Food and Drug Administration granted priority review for the supplemental new drug application for its drug Invokana to treat kidney disease in diabetes patients.
J&J's Janssen unit is applying for the approval of Invokana in reducing the risk of end-stage kidney disease or renal failure; the doubling of creatinine level in the blood, a measure of how well the kidneys filter; and renal or cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
If approved, Invokana, also called canagliflozin, will be the first and only medicine to treat chronic kidney disease in type 2 diabetes patients, New Brunswick, N.J.-based J&J said.
The application was based on a late-stage study, dubbed Credence, which showed that Invokana, combined with standard of care therapy, reduced the risk of kidney failure in high-risk patients with chronic kidney disease and type 2 diabetes — the leading cause of kidney failure worldwide.
In October 2018, the FDA approved Invokana to treat patients with cardiovascular disease, reducing the risk of heart attack, stroke or death. Invokana is in a class of drugs called sodium-glucose cotransporter-2, or SGLT2, inhibitors that help diabetes patients control blood sugar.
Invokana is licensed from Osaka, Japan-based Mitsubishi Tanabe Pharma Corp.