FDA Approves Canagliflozin Indication Expansion

September 30, 2019

Now approved for risk reductions in patients with type 2 diabetes mellitus.

The FDA has approved Canagliflozin (Invokana, Johnson & Johnson) oral tablets for the reduction of the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria. 

Canagliflozin is a sodium-glucose co-transporter 2 inhibitor that was first approved by the FDA in 2013 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The medication gained an additional indication in 2018 for the reduction of the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. 

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“With the approval of these new uses, canagliflozin 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 James List, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC, in a statement. “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.”

The approval is based upon results from recently completed CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) Study NCT02065791. 4,401 patients from 34 countries with T2D and established stage 2 or 3 chronic kidney disease (CKD) who were receiving a standard of care that included the maximum tolerated labeled daily dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers were randomized in a 1:1 ratio to receive either canagliflozin 100 mg or matching placebo, with a mean follow-up of 2.62 years. 

Overall, results from the study indicate that canagliflozin reduced the risk of cardiovascular death, heart attack, and stroke by 20% compared to placebo. According to the study’s release, cardiovascular death, heart attack, and stroke were reduced by 32% in the primary prevention group and by 15% in the secondary prevention group. The incidence rates of adverse events were also lowered in patients treated with canagliflozin. 

“We know that the real battle to turn the tide on kidney disease is in early detection and slowing its progression so that patients stay healthier and fewer patients reach kidney failure. We are so grateful that advances in kidney disease research are producing treatment options that help to slow the progression of diabetic kidney disease and reduce the risk of hospitalization for heart failure,” said LaVerne A. Burton, President and Chief Executive Officer, American Kidney Fund, in a statement. 

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Canagliflozin is contraindicated in patients with known serious hypersensitivity to canagliflozin, severe renal impairment (eGFR < 30 mL/min/1.73 m2) in patients being treated for glycemic control, and those on dialysis. 

Canagliflozin comes with a boxed warning of associated lower limb amputations frequently isolated to the toe and mid-foot, in patients with type 2 diabetes who have established or are at risk for cardiovascular disease.

Other warnings and precautions issued with the use of canagliflozin include hypotension, ketoacidosis, acute kidney injury, urosepsis and pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum, genital mycotic infections, hypersensitivity reactions, bone fracture. 

Adverse events commonly reported with the use of canagliflozin include female genital mycotic infections, urinary tract infection, and increased urination. 

 

Full Prescribing Information