The U.S. Food and Drug Administration (FDA) approved a new indication for Janssen Pharmaceutical’s Invokana (R) today.
The new indication is to reduce the risk of end-stage kidney disease and cardiovascular events in patients with Type 2 diabetes and chronic kidney disease.
Invokana is now the only Type 2 diabetes medicine indicated to both treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with Type 2 diabetes and diabetic nephropathy.
Type 2 diabetes is the leading cause of kidney disease in the U.S. and the fifth fastest-growing cause of death around the world.
“With the approval of these new uses, Invokana is now the only diabetes medicine indicated to help Type 2 diabetes patients reduce the risks associated with diabetic kidney disease, including hospitalization for heart failure,” said Dr. James List, global therapeutic area head, cardiovascular & metabolism, Janssen Research & Development, LLC.
“This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with Type 2 diabetes and diabetic kidney disease,” he added.
With this approval, Invokana is the only Type 2 diabetes medicine indicated to reduce the risk of hospitalization for heart failure in patients with Type 2 diabetes and diabetic nephropathy and is the first new treatment option in nearly 20 years indicated to slow the progression of kidney disease in these patients.
The new indication is based on results from the landmark Phase 3 Credence study in patients with Type 2 diabetes and diabetic nephropathy, which was stopped early because it met the prespecified criteria for efficacy.
In the trial, Invokana 100 mg demonstrated a 30 percent reduction in the risk of the primary composite endpoint, comprising end-stage kidney disease (ESKD), doubling of serum creatinine and renal or CV death.
Results also showed Invokana reduced the risk of secondary CV endpoints, including a 39 percent reduction in the risk of hospitalization for heart failure.
Overall, adverse events and serious adverse events were similar but numerically lower in the Invokana group compared to placebo.
The rates of diabetic ketoacidosis and genital mycotic infections were numerically higher in theInvokana group, as observed in other clinical trials. Additionally, there was no imbalance in lower limb amputation or bone fracture in this trial and no new safety signals were identified.
The National Kidney Foundation applauded Janssen for bringing forth this new treatment and urged patients to discuss the implications of this new option with their healthcare professionals.
For more information, you can view the full company press release here.
- Janssen Pharmaceutical Companies of Johnson & Johnson. (2019, September 30). PR Newswire. Retrieved September 30, 2019, from https://www.prnewswire.com/news-releases/us-fda-approves-invokana-canagliflozin-to-treat-diabetic-kidney-disease-dkd-and-reduce-the-risk-of-hospitalization-for-heart-failure-in-patients-with-type-2-diabetes-t2d-and-dkd-300927348.html