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United Kingdom : INVOKANA (canagliflozin) Significantly Reduces the Risk of Renal Failure in Patients with Type 2 Diabetes and Chronic Kidney Disease in the Landmark.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new results from the Phase 3 CREDENCE study, showing that INVOKANA (canagliflozin) demonstrated a 30 percent reduction in the risk of the primary composite endpoint, comprised of progression to end-stage kidney disease (ESKD), defined as the need for renal replacement therapy (RRT) such as chronic dialysis or renal transplant; doubling of serum creatinine, a key predictor of ESKD; and renal or cardiovascular (CV) death.

The landmark study evaluated the efficacy and safety of INVOKANA versus placebo in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) when used in addition to standard of care. Study results also showed INVOKANA reduced the risk of the secondary CV endpoints, including the risk of CV death and hospitalization for heart failure by 31 percent, major adverse CV events (MACE; composite of nonfatal myocardial infarction MI , nonfatal stroke and CV death) by 20 percent, and the risk of hospitalization for heart failure alone by 39 percent. Importantly, the study showed no imbalance in amputation or bone fracture. Additionally, no new safety concerns were identified in this study of high-risk patients.

The data were presented today during a late-breaking clinical trials session at the International Society of Nephrology (ISN) 2019 World Congress of Nephrology (WCN) in Melbourne, Australia, and simultaneously published in The New England Journal of Medicine. Canagliflozin is the first medical breakthrough in nearly twenty years proven to slow the progression of chronic kidney disease in patients with diabetes at high risk of developing kidney failure, said Vlado Perkovic i , M.B.B.S, Ph.D., F.A.S.N., F.R.A.C.P., CREDENCE Steering Committee co-chair, Executive Director, The George Institute for Global Health, Australia and Professor of Medicine, UNSW Sydney. 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.

Diabetes is the leading cause of kidney failure for millions of people worldwide, and this clear need for a new treatment option was the motivation for initiating the CREDENCE study. Today, 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, said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. 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.

The Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation, NCT02065791) clinical trial was a randomized, double-blind, event-driven, placebo-controlled, parallel-group, 2-arm, multicenter study. It evaluated 4,401 patients with T2D, Stage 2 or 3 CKD (defined as an estimated glomerular filtration rate (eGFR) of ?30 to 300 to ?5,000 mg/g), who were receiving standard of care including a maximum tolerated labeled daily dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).

At Janssen, we tackle some of the worlds most challenging and burdensome diseases, both by exploring the ability of our established medicines to meet unmet patient needs and by leveraging the cutting edge of science to develop entirely new medicines, said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. The CREDENCE clinical trial results demonstrate our commitment to helping patients, and bring us one step closer to treating the comorbidities associated with type 2 diabetes and meeting the unmet needs of the millions of people living with chronic kidney disease.

In March 2019, Janssen included the CREDENCE data in the submission of a supplemental New Drug Application to the U.S. FDA for INVOKANA to reduce the risk of ESKD, the doubling of serum creatinine, and renal or CV death for adults with CKD and T2D. This followed an Independent Data Monitoring Committee meeting in July 2018, where the committee recommended that the CREDENCE trial stop early because it met the prespecified criteria for efficacy. If this new indication is approved, INVOKANA would be the first diabetes medication 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.

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Publication:Mena Report
Date:Apr 20, 2019
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