The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending that approval for the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Janssen) be extended to include the treatment of diabetic kidney disease.
The agent is already marketed for type 2 diabetes; the new indication is based on results from the CREDENCE trial of patients with type 2 diabetes and chronic kidney disease, as reported by Medscape Medical News in April 2019.
In CREDENCE, canagliflozin was associated with a 30% reduction in the risk of the primary composite endpoint, comprising end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. The results also showed canagliflozin reduced the risk of secondary cardiovascular endpoints, including a 39% reduction in the risk of hospitalization for heart failure.
First Agent to Slow Progression of Diabetic Nephropathy in Almost 20 Years
If approved, which is normally a formality within 60 days, canagliflozin will be the first therapy approved in the EU in nearly 20 years, since the approval of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers, to slow the progression of diabetic kidney disease in patients with type 2 diabetes, including those with moderate and severe renal impairment.
The approval will cover patients with a urinary albumin/creatinine ratio > 300 mg/g and estimated glomerular filtration rate (eGFR) down to 30 mL/min/1.73m2. This will allow continued use until renal replacement therapy, recognizing the cardiovascular and renal benefits of canagliflozin in type 2 diabetes even at eGFR levels < 30 mL/min/1.73m2.
The US FDA approved a similar indication for canagliflozin, based on the CREDENCE data, in September last year.
And in June 2019, the American Diabetes Association (ADA) updated its Standards of Medical Care in Diabetes to incorporate the findings from CREDENCE.
CREDENCE investigator Meg Jardine, MBBS, PhD, from The George Institute for Global Health, Sydney, Australia, told Medscape Medical News at the time the CREDENCE results were revealed that the study is "a game changer, a whole new strategy we can use."
"Patients in the CREDENCE trial got the standard of care and investigators were encouraged to optimize their blood sugar and blood pressure control, but even beyond that we saw these powerful effects," she added.
Renal Trials for Other SGLT2 Inhibitors, Dapagliflozin and Empagliflozin
DAPA-CKD, the renal outcomes trial of another SGLT2 inhibitor, dapagliflozin (Forxiga/Farxiga, AstraZeneca), in 4000 patients was stopped early at the end of March 2020 because of overwhelming efficacy of the drug based on the recommendation of an independent data monitoring committee.
Full results of DAPA-CKD will be presented at an upcoming medical meeting.
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Cite this: EU Green Light for Canagliflozin to Slow Diabetic Kidney Disease - Medscape - Jun 01, 2020.