A little more than one year after posting landmark data, Janssen’s Invokana snagged another regulatory approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
On Monday, the U.S. Food and Drug Administration (FDA) awarded Invokana with the new indication. Specifically, the FDA approved Invokana (canagliflozin) as a treatment to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine. The approvals marks Invokana as 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 T2D and diabetic kidney disease (DKD). T2D is the leading cause of kidney disease in the United States and the fifth fastest-growing cause of death around the world, Janssen noted in its announcement.
James List, global therapeutic head for cardiovascular & metabolism at Janssen Research & Development, touted the approval as a significant new treatment option for diabetic patients. He said the approval “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.”
The approval was based on the landmark CREDENCE trial after Invokana demonstrated a 30% 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%. The medication also reduced major adverse CV events, including nonfatal stroke and CV death, by 20%. The risk of hospitalization for heart failure was reduced by 39%. Also, the CREDENCE study showed no imbalance in amputation or bone fracture, Janssen said.
In the United States, one in three people with T2D has DKD, which multiplies the risk of cardiovascular complications including heart failure and CV death, and puts patients on a trajectory to dialysis and kidney transplant. With this approval, Invokana is the only type 2 diabetes medicine indicated to reduce the risk of hospitalization for heart failure in patients with T2D and DKD, and is the first new treatment option in nearly 20 years indicated to slow the progression of DKD in these patients, Janssen said.
CREDENCE study investigator George Bakris, director of the Comprehensive Hypertension Center at the University of Chicago, said millions of type 2 diabetes patients have DKD and most are not aware of the situation. By the time it is diagnosed, Bakris said the patients have progressed to the point where dialysis is inevitable.
“For nearly two decades, we’ve been searching for a treatment that can help us intervene earlier to slow kidney disease progression. With the approval for this new indication for Invokana, physicians will not only be able to help reduce the risks associated with diabetic kidney disease, but also reduce the risk of hospitalization for heart failure in patients with T2D and DKD,” Bakris said in a statement.
Invokana, a sodium glucose co-transporter 2 (SGLT2) inhibitors, has previously been approved by the U.S. Food and Drug Administration as a treatment to improve glycemic control in adults with type 2 diabetes. SGLT2s are proteins found in the kidneys that are important in the reabsorption of glucose by the kidneys. The drug does come with a black box warning for an increased risk of lower-limb amputations. In the CREDENCE trial, Janssen said there was no imbalance in lower limb amputation or bone fracture in this trial and no new safety signals were identified.