J&J stops Invokana trial early after success in kidney disease and type 2 diabetes
pharmafile | July 17, 2018 | News story | Manufacturing and Production, Research and Development | J&J, JJ, Janssen, Johnson & Johnson, invokana, kidney disease, pharma, renal, type 2 diabetesm diabetes
Johnson & Johnson and research arm Janssen have taken the decision to terminate a Phase 3 trial evaluating the efficacy of its SGLT2 inhibitor Invokana (canagliflozin), but not because it had proved ineffective.
On the contrary, after the drug met its pre-specified efficacy criteria in the prevention of clinically important renal and cardiovadcvular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), the company deemed it pertinent to close the study early.
The decision was made on the back of a recommendation from an Independent Data Monitoring Committee on the study that met during a predetermined interim analysis. In 4,400 participants with T2B as part of the CREDENCE study – the first trial investigating renal outcomes in CKD and T2D patients on the background of standard of care, including angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers – Invokana met its primary composite endpoint of end-stage kidney disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular (CV) death, when used in addition to standard of care.
“Nearly half of all people with type 2 diabetes will develop chronic kidney disease, causing a high risk of kidney failure and cardiovascular disease, and impacting their quality and length of life, even with the current best available care. This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago,” said Dr Vlado Perkovic, CREDENCE Steering Committee co-chair, Professor of Medicine, University of New South Wales Sydney, and Executive Director, The George Institute for Global Health Australia. “We have accepted the advice of the Independent Data Monitoring Committee to stop the CREDENCE trial early due to demonstration of efficacy, and look forward to sharing the findings as soon as possible.”
Dr James List, Global Therapeutic Area Head, Cardiovascular & Metabolism at Janssen, also remarked: “Chronic kidney disease is a progressive condition that impacts a person’s overall health and well-being, and with millions of people worldwide suffering from the disease, we know that there is a clear need for new treatment options. We are excited about the possibility of bringing forth Invokana as the first therapy to treat patients with chronic kidney disease and type 2 diabetes in more than 15 years. We look forward to presenting the full data from the CREDENCE trial at an upcoming medical meeting and with health authorities in the near future.”
Matt Fellows
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