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Janssen submits supplemental NDA for canagliflozin after positive renal findings
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Janssen on Thursday submitted a supplemental new drug application to the FDA seeking a new indication for the SGLT2 inhibitor canagliflozin to reduce the risk for end-stage renal disease, the doubling of serum creatinine, and renal or cardiovascular death in adults with type 2 diabetes and chronic kidney disease, according to a press release from the company.
The submission is based on results from the phase 3 CREDENCE study, which evaluated the efficacy and safety of canagliflozin (Invokana) vs. placebo for adults with type 2 diabetes and CKD. As Endocrine Today previously reported, the steering committee behind the CREDENCE trial announced an early stop of the study in July based on the achievement of prespecified efficacy criteria. Canagliflozin is currently contraindicated for patients with severe renal impairment, defined as an estimated glomerular filtration rate of less than 30 mL/min/1.73 m², or ESRD and for patients on dialysis. Additionally, canagliflozin is not recommended in patients with an eGFR that is persistently lower than 45 mL/min/1.73 m².
If approved, canagliflozin will be the first diabetes medicine for the treatment of people living with type 2 diabetes and CKD.
“Today, millions of people living with type 2 diabetes and chronic kidney disease are at high risk of experiencing kidney failure, and unfortunately, we have not seen treatment innovation for these patients in almost 20 years,” James List, MD, PhD, global therapeutic area head of cardiovascular and metabolism for Janssen Research & Development, said in the release. “Janssen’s application is a significant step toward bringing a much-needed, new standard of care for those living with these serious conditions. We look forward to presenting the CREDENCE data at the [International Society of Nephrology] World Congress of Nephrology and working closely with the FDA to bring this important medicine as quickly as possible to people living with type 2 diabetes and chronic kidney disease.”
The CREDENCE trial, originally estimated to be completed by 2020, was designed to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes, stage 2 or 3 CKD and macroalbuminuria. The trial enrolled 4,401 patients with type 2 diabetes, an eGFR between 30 mL/min/1.73 m² and 90 mL/min/1.73 m² and a urinary albumin to creatinine ratio between 300 mg/g and 5,000 mg/g. All patients were on the maximum labeled or tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blockers for more than 4 weeks before randomization.
Primary investigators will present the CREDENCE data during a late-breaking clinical trials session at the International Society of Nephrology World Congress of Nephrology Annual Meeting in Melbourne, Australia, on April 15. – by Regina Schaffer
Disclosure: List is global therapeutic area head of cardiovascular and metabolism for Janssen Research & Development.