Janssen Presents Landmark Data From Invokana Study
Janssen Presents Landmark Data From Positive Invokana Trial Halted Early at Australia Conference
Janssen’s Invokana has become the only medicine in nearly 20 years and the first diabetes medicine ever to demonstrate a reduction in progression to end-stage renal failure in Type 2 diabetes patients with chronic kidney disease, the company said.
At the International Society of Nephrology 2019 World Congress of Nephrology in Melbourne, Australia, Janssen presented data from its Phase III CREDENCE study that showed Invokana demonstrated a significant risk reduction of renal failure, dialysis or kidney transplantation and renal and CV death in this patient population. The CREDENCE study was halted early for positive efficacy findings and served as the basis for Janssen’s March 2019 filing of a supplemental New Drug Application to the U.S. Food and Drug Administration for Invokana. If the new indication for Invokana is approved, Janssen said the medication will be the first diabetes treatment to treat both T2D and CKD, and could be an important new treatment option for the millions of patients around the world who live with these illnesses.
The study evaluated the efficacy and safety of Invokana versus placebo in patients with chronic kidney disease and type 2 diabetes when used in addition to standard of care. Data from the late-stage trial showed that Invokana showed a 30 percent reduction in the risk of the primary composite endpoint, which was comprised of progression to doubling of serum creatinine, ESKD and renal or CV death. Invokana reduced the risk of CV death and hospitalization for heart failure by 31 percent. The medication also reduced major adverse CV events, including nonfatal stroke and CV death, by 20 percent. The risk of hospitalization for heart failure was reduced by 39 percent. Also, the CREDENCE study showed no imbalance in amputation or bone fracture, Janssen said.
No new safety concerns were identified in this study of high-risk patients.
Vlado Perkovic, the steering committee chair for the CREDENCE trial and executive director of The George Institute for Global Health, Australia, said Invokana is the first medical breakthrough in nearly 20 years proven to slow the progression of chronic kidney disease in patients with diabetes at high risk of developing kidney failure.
“These impressive results from the CREDENCE study have significant clinical implications for preventing kidney failure and improving health for millions of people living with chronic kidney disease and type 2 diabetes,” Perkovic said in a statement.
James List, Global Therapeutic Area Head of Cardiovascular & Metabolism at Janssen Research & Development, said researchers at Janssen saw a clear need for the development of a treatment for these patients. List noted that diabetes is a leading cause of kidney failure and about half of all people with type 2 diabetes will end up with chronic kidney disease. That will lead to a high risk of kidney failure and cardiovascular disease. A new treatment option for this was critical for the millions of diabetes patients across the globe, he said.
“… we are pleased to share study results that potentially could establish Invokana as the only medicine to safely reduce the risk of renal failure in this high-risk patient population when added to current standard of care,” List said in a statement. “We are working closely with the U.S. FDA and health authorities worldwide to bring this important medicine to those living with these life-threatening conditions.”
Invokana, a sodium glucose co-transporter 2 (SGLT2) inhibitors, has been approved by the U.S. Food and Drug Administration as a treatment to improve glycemic control in adults with type 2 diabetes. The drug does come with a black box warning for an increased risk of lower limb amputations.