Janssen’s Invokana combo smashes primary and secondary endpoints in chronic kidney disease
pharmafile | April 16, 2019 | News story | Manufacturing and Production, Research and Development | Janssen, cardiovascular, chronic kidney disease, diabetes, invokana, pharma
Janssen has unveiled promising new Phase 3 for its sodium-glucose transport (SGLT) protein-2 inhibitor Invokana (canagliflozin), showing that the therapy met its primary endpoint in the treatment of chronic kidney disease (CKD) and type 2 diabetes (T2D) when used in addition to standard of care.
In 4,401 participants with T2D or stage 2 or 3 CKD, the therapy reduced in the risk of progression to end-stage kidney disease (ESKD), doubling of serum creatinine, and renal or cardiovascular (CV) death by 30%.
The combo also lowered the risk of major adverse CV .events (MACE), including composite of nonfatal myocardial infarction, nonfatal stroke and CV death, by 20%.
Additionally, risk of hospitalisation for heart failure alone was cut by 39%, ESKD disease risk was reduced by 32%, and the risk of CV death and hospitalisation for heart failure was slashed by 31%.
“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 Dr Vlado Perkovic, CREDENCE Steering Committee co-chair, Executive Director at The George Institute for Global Health and Professor of Medicine at 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.”
Dr James List, Global Therapeutic Area Head, Cardiovascular & Metabolism at Janssen, added: “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. We are working closely with the US FDA and health authorities worldwide to bring this important medicine to those living with these life-threatening conditions.”
Janssen is currently pursuing regulatory approval in the US, and would be the first FDA-approved diabetes therapy to treat both T2D and CKD. In the EU, Mundipharma handles the marketing for the drug following a licensing agreement with Janssen in September 2017.
Matt Fellows
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