-INVOKANA® is the only medicine in nearly 20 years and the first diabetes medicine to demonstrate significant reduction in risk of renal failure, dialysis or kidney transplantation, and renal or cardiovascular death in this high-risk patient population
-In the study, INVOKANA® significantly reduced the combined risk of cardiovascular death, myocardial infarction, and stroke, and demonstrated no imbalance in amputation or bone fracture
-The CREDENCE study was halted early for positive efficacy findings and served as the basis for Janssen’s March 2019 filing of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for INVOKANA®
MELBOURNE, Australia I April 14, 2019 I 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 Perkovici, 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 <90 mL/min/1.73 m2), and macroalbuminuria (defined as urinary albumin-to-creatinine ratio (ACR) >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 world’s 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.
Study Results
In the CREDENCE study, INVOKANA® showed a 30 percent reduction in the risk of the primary composite endpoint – comprised of progression to doubling of serum creatinine, ESKD, and renal or CV death (HR: 0.70; 95% CI: 0.59 to 0.82; p<0.0001). These findings were consistent across the individual components of the primary composite endpoint, as well as across all 15 prespecified subgroups tested. INVOKANA® reduced the risk of end-stage kidney disease by 32 percent (HR: 0.68; 95% CI: 0.54 to 0.86; p=0.0015).
Furthermore, INVOKANA® showed a 20 percent reduction in the risk of the secondary endpoints of MACE, which is composed of nonfatal MI, nonfatal stroke, and CV death (HR: 0.80; 95% CI: 0.67 to 0.95; p=0.0121), a 31 percent reduction in the risk of the composite of CV death and hospitalization for heart failure (HR: 0.69; 95% CI: 0.57 to 0.83; p=0.0001), and a 39 percent reduction in the risk of hospitalization for heart failure alone (HR: 0.61; 95% CI: 0.47 to 0.80; p=0.0003).
The incidence rates of adverse events and serious adverse events were numerically lower for patients treated with INVOKANA® as compared to placebo. There were no observed differences in the incidence of amputations (HR: 1.11; 95% CI: 0.79 to 1.56) or adjudicated fractures (HR: 0.98; 95% CI: 0.70 to 1.37).
At this time, INVOKANA®, which is currently indicated for the treatment of glycemia in patients with T2D and the reduction in MACE in patients with T2D and established CV disease, is contraindicated for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), ESKD, or patients on dialysis. In addition, INVOKANA® is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2. Please see the Important Safety Information below and the full Prescribing Information for additional details.
WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used:
- along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
- to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.
About Janssen Cardiovascular & Metabolism
In Cardiovascular & Metabolism (CVM), we take on the most pervasive diseases that burden hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and propelled by our successes in treating type 2 diabetes (T2D) and thrombosis, we advance highly differentiated therapies that prevent and treat life-threatening cardiovascular, metabolic and retinal diseases. Uncovering new therapies that can improve the quality of life for this large segment of the population is an important endeavor – one which Janssen CVM will continue to lead in the years to come. Our mission is global, local and personal. Together, we can reshape the future of cardiovascular, metabolic and retinal disease prevention and treatment. Please visit www.janssen.com/cardiovascular-and-metabolism.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
SOURCE: Janssen
Post Views: 30
-INVOKANA® is the only medicine in nearly 20 years and the first diabetes medicine to demonstrate significant reduction in risk of renal failure, dialysis or kidney transplantation, and renal or cardiovascular death in this high-risk patient population
-In the study, INVOKANA® significantly reduced the combined risk of cardiovascular death, myocardial infarction, and stroke, and demonstrated no imbalance in amputation or bone fracture
-The CREDENCE study was halted early for positive efficacy findings and served as the basis for Janssen’s March 2019 filing of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for INVOKANA®
MELBOURNE, Australia I April 14, 2019 I 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 Perkovici, 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 <90 mL/min/1.73 m2), and macroalbuminuria (defined as urinary albumin-to-creatinine ratio (ACR) >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 world’s 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.
Study Results
In the CREDENCE study, INVOKANA® showed a 30 percent reduction in the risk of the primary composite endpoint – comprised of progression to doubling of serum creatinine, ESKD, and renal or CV death (HR: 0.70; 95% CI: 0.59 to 0.82; p<0.0001). These findings were consistent across the individual components of the primary composite endpoint, as well as across all 15 prespecified subgroups tested. INVOKANA® reduced the risk of end-stage kidney disease by 32 percent (HR: 0.68; 95% CI: 0.54 to 0.86; p=0.0015).
Furthermore, INVOKANA® showed a 20 percent reduction in the risk of the secondary endpoints of MACE, which is composed of nonfatal MI, nonfatal stroke, and CV death (HR: 0.80; 95% CI: 0.67 to 0.95; p=0.0121), a 31 percent reduction in the risk of the composite of CV death and hospitalization for heart failure (HR: 0.69; 95% CI: 0.57 to 0.83; p=0.0001), and a 39 percent reduction in the risk of hospitalization for heart failure alone (HR: 0.61; 95% CI: 0.47 to 0.80; p=0.0003).
The incidence rates of adverse events and serious adverse events were numerically lower for patients treated with INVOKANA® as compared to placebo. There were no observed differences in the incidence of amputations (HR: 1.11; 95% CI: 0.79 to 1.56) or adjudicated fractures (HR: 0.98; 95% CI: 0.70 to 1.37).
At this time, INVOKANA®, which is currently indicated for the treatment of glycemia in patients with T2D and the reduction in MACE in patients with T2D and established CV disease, is contraindicated for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), ESKD, or patients on dialysis. In addition, INVOKANA® is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2. Please see the Important Safety Information below and the full Prescribing Information for additional details.
WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used:
- along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
- to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.
About Janssen Cardiovascular & Metabolism
In Cardiovascular & Metabolism (CVM), we take on the most pervasive diseases that burden hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and propelled by our successes in treating type 2 diabetes (T2D) and thrombosis, we advance highly differentiated therapies that prevent and treat life-threatening cardiovascular, metabolic and retinal diseases. Uncovering new therapies that can improve the quality of life for this large segment of the population is an important endeavor – one which Janssen CVM will continue to lead in the years to come. Our mission is global, local and personal. Together, we can reshape the future of cardiovascular, metabolic and retinal disease prevention and treatment. Please visit www.janssen.com/cardiovascular-and-metabolism.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
SOURCE: Janssen
Post Views: 30
