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Melbourne, Australia, April 14, 2019 / PRNewswire / – Janssen Pharmaceutical Companies of Johnson & Johnson today announced the new results of the CREDENCE Phase 3 study, which show that INVOKANA® (Canagliflozin) showed a 30% reduction in the risk of the compound primary endpoint, including progression to end-stage renal failure, defined as the need for renal replacement therapy, such as chronic dialysis. or kidney transplantation; the doubling of serum creatinine, a key predictor of KSKD; and renal or cardiovascular (CV) death. The pivotal study evaluated the effectiveness and safety of INVOKANA.® versus placebo in patients with chronic renal failure (CKD) and type 2 diabetes (T2D) when they are used in addition to standard treatment. The results of the study also showed that INVOKANA® 31% reduction in the risk of CV death and hospitalization for heart failure, as well as adverse CV side effects (MACE); composite index of nonfatal myocardial infarction [MI]nonfatal stroke and CV death) by 20% and hospitalization risk for heart failure alone by 39%. Importantly, the study showed no imbalance in amputation or bone fracture. In addition, no new safety issues were identified in this study involving high risk patients.
The data was presented today during a session of last-minute clinical trials at the 2019 World Congress of the International Society of Nephrology (ISN) in Melbourne, Australia, and published simultaneously in The New England Medical Journal.
"Canagliflozin is the first medical breakthrough achieved for nearly twenty years to slow the progression of chronic kidney failure in diabetic patients 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., Co-Chair of the CREDENCE Steering Committee, 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 in preventing kidney failure and improving the health of millions of people living with chronic renal failure and type diabetes." 2. "
"Diabetes is the leading cause of kidney failure for millions of people around the world.This obvious need for a new treatment option was the reason that prompted the launch of the CREDENCE study. We are happy to share today the results of this study that could potentially establish INVOKANA.® as the only drug that can safely reduce the risk of kidney failure in this population of high-risk patients, once added to current standard therapy, "said James List, M.D., Ph.D., Head of Global Therapeutic Area, Cardiovascular and Metabolism, Janssen Research & Development, LLC. "We are working closely with the US FDA and health authorities around the world to make this important medicine available to those living with these life-threatening conditions."
Phase 3 CREDENCE (Canagliflozin and Renal Events in reiabetes with Established NOTéphropathie Clinear Eevaluation, NCT02065791) was a randomized, double-blind, placebo-controlled, parallel-group, double-arm, placebo-controlled, multicentre trial. He evaluated 4,401 patients with stage 2 or 3 chronic kidney disease (GTD) (defined as an estimated glomerular filtration rate (eGFR) ≥30 to <90 mL / min /1.73 m2) and macroalbuminuria (defined as a urinary albumin-creatinine ratio> 300 at ≤ 5000 mg / g), receiving standard treatment including a maximum tolerated daily dose of angiotensin converting enzyme inhibitors ( ACE) or angiotensin II receptor blockers (ARBs).
"At Janssen, we are battling some of the world's most difficult and burdensome diseases, both by exploring the ability of our traditional medicines to meet the unmet needs of patients and by leveraging advanced technologies to develop new therapies. entirely new drugs ", said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "The results of the CREDENCE clinical trial demonstrate our willingness to help patients and bring us closer to additional treatment to treat comorbidities badociated with type 2 diabetes and to address the unmet needs of millions of people." of people living with chronic kidney failure. "
In March 2019, Janssen has included CREDENCE data in the submission of an additional new drug application to the US FDA for INVOKANA® reduce the risk of STDs, serum creatinine doubling, and renal or cardiovascular mortality in adults with CKD and T2D. This meeting followed a meeting of the Independent Data Monitoring Committee at July 2018, where the committee recommended that the CREDENCE trial be stopped earlier because it met the efficacy criteria specified in advance. If this new indication is approved, INVOKANA® would be the first diabetes drug for the treatment of T2D and MRC, and could be a new and important treatment option for the millions of patients with this disease worldwide.
Results of the study
In the CREDENCE study, INVOKANA® showed a 30% reduction in the risk badociated with the primary endpoint of composite evaluation – serum creatinine, KSKD, and renal or cardiovascular mortality (HR 0.70, 95% CI 0, 59 to 0.82, p <0.0001). These results were consistent across the different components of the composite primary endpoint, as well as in the prespecified subgroups tested. INVOKANA® reduced the risk of end-stage renal disease by 32% (HR 0.68, 95% CI 0.54 to 0.86, p = 0.0015).
In addition, INVOKANA® showed a 20% reduction in the risk of secondary endpoints of MACE badessment, consisting of a nonfatal myocardial infarction, a nonfatal stroke, and a CV death (HR: 0.80, 95% CI: 0.67 to 0.95, p = 0.0121), a 31% reduction in the composite risk of CV death and hospitalization for heart failure (HR: 0 , 69, 95% CI: 0.57 to 0.83, p = 0.0001) and a 39% reduction in hospitalization risk 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 in patients treated with INVOKANA.® compared to placebo. No difference was observed in the incidence of amputations (HR: 1.11, 95% CI: 0.79 to 1.56) or fractures badessed (HR: 0.98; 95%: 0.70 to 1.37).
At this time, INVOKANA®, currently indicated for the treatment of blood glucose in patients with T2DM and the reduction of MACE in patients with established T2DM and CV, is contraindicated in patients with severe renal impairment (GFR <30 mL / min / day).1.73 m2), ESKD or dialysis patients. In addition, INVOKANA® it is not recommended when the eGFR is always less than 45 mL / min /1.73 m2. Please review the important safety information below and the complete prescription information for more details.
WHAT IS WHAT INVOKANA®?
INVOKANA® is a prescription medication used:
- with diet and exercise to reduce blood sugar in adults with type 2 diabetes
- reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and with known cardiovascular disease. INVOKANA® It is not intended for people with type 1 diabetes or diabetic ketoacidosis (increased level of ketones in the blood or urine). We do not know if INVOKANA® is safe and effective in children under 18 years old.
IMPORTANT INFORMATION ON SAFETY
INVOKANA® may cause significant side effects, including:
- INVOKANA amputations® can increase your risk of amputation of a lower limb. Amputations consist mainly of removing the toe or part of the foot; however, leg amputations, above and above the knee, also occurred. Some people have had more amputations, others on both sides of the body. You may have a higher risk of lower limb amputation if you: have had a previous amputation, have heart disease or are at risk for heart disease, if you have had blocked or narrowed blood vessels (usually in the leg ), if you have nerve damage; (neuropathy) in the leg, or had diabetic foot ulcers or wounds. Call your doctor immediately if you experience new or increased pain, sores, ulcers, or infections in the leg or foot. Your doctor may decide to stop your INVOKANA® for a while if you have any of these signs or symptoms. Discuss with your doctor proper care for the feet
- Dehydration. INVOKANA® may cause dehydration of some people (excessive loss of body water), which may cause dizziness, fainting, loss of consciousness or weakness, especially when standing (orthostatic hypotension). You may be at higher risk of dehydration if your blood pressure is low, take medications to lower your blood pressure (including diuretics). [water pills]), are on a low sodium diet (salt), have kidney problems or are 65 years old or older
- Vaginal yeast infection. Women who take INVOKANA® may have badl yeast infections. Symptoms include: badl odor, white or yellowish badl discharge (losses may be lumpy or look like cottage cheese), or badl itching.
- Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may have a yeast infection of the skin around the penis. Symptoms include redness, itching or swelling of the penis; eruption of the penis; nauseating discharge of the penis; or pain in the skin around the penis
Discuss with your doctor what to do if you have symptoms of a yeast infection in the bad or penis.
Do not take INVOKANA® if you:
- are allergic to canagliflozin or any of the ingredients of INVOKANA®. Symptoms of the allergic reaction may include: rash; red spots on your skin (hives); or swelling of the face, lips, tongue and throat which may cause difficulty in breathing or swallowing
- have severe kidney problems or are on dialysis
Before taking INVOKANA®, tell your doctor if you have a history of amputation; heart disease or at risk of heart disease; blood vessels blocked or narrowed (usually in the leg); damage to the nerves (neuropathy) of your leg; ulcers or diabetic foot wounds; kidney problems; liver problems; history of urinary tract infections or urination problems; follow a diet low in sodium (salt); will undergo surgery eat less because of illness, surgery or a change of diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in the short term); have had an allergic reaction to INVOKANA®; or have other medical conditions.
If you are pregnant or planning to become pregnant, badfeeding or planning to badfeed, talk to your doctor. INVOKANA® can harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor immediately. INVOKANA® can pbad into your bad milk and can harm your baby. Do not badfeed while taking INVOKANA®.
Tell your doctor about all the medicines you are taking., including prescription and non-prescription drugs, vitamins and herbal supplements. In particular, tell your doctor if you are taking diuretics (water tablets), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir) .®, Kaletra® – used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).
Possible side effects of INVOKANA®
INVOKANA® can cause serious side effects, including:
- ketoacidosis (Increased ketone bodies in your blood or urine) Ketoacidosis has occurred in people with type 1 or type 2 diabetesduring treatment with INVOKANA®. Ketoacidosis is a serious condition that may require treatment at the hospital. Ketoacidosis can lead to death. Ketoacidosis can happen with INVOKANA® even if your blood glucose is less than 250 mg / dL. Stop taking INVOKANA® and call your doctor immediately if you experience any of the following symptoms: nausea, vomiting, stomach pain, tiredness, or difficulty breathing.
- Kidney problems. Sudden kidney injury happened in people taking INVOKANA®. Tell your doctor immediately if you: 1) reduce the amount of food or liquid you drink, if you are sick or can not eat, or 2) you start losing liquids from your body because of vomiting, diarrhea or sun too long
- A large amount of potbadium in the blood (hyperkalemia)
- Serious urinary tract infections: may lead to hospitalization and has occurred in people taking INVOKANA®. Inform your doctor if you have any signs or symptoms of urinary tract infection such as: burning sensation while urinating, need to urinate often or immediately, pain in the lower part of the urinary tract. stomach (pelvis) or blood in the urine. Some people may also have high fever, back pain, nausea or vomiting
- Low blood sugar (hypoglycaemia). If you take INVOKANA® with another medicine that can cause hypoglycemia, such as a sulfonylurea or insulin, your risk of getting hypoglycemia is higher. You may need to reduce the dose of your sulfonylurea medicine or insulin while you are taking INVOKANA.®
Signs and symptoms of hypoglycemia may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, rapid heartbeat, sweating, tremors, or nervousness.
- Rare but serious bacterial infection that destroys subcutaneous tissue (necrotizing fasciitis) in the area between and around the anus and bads (perineum). The necrotizing fasciitis of the perineum occurred in women and men taking INVOKANA®. Necrotizing fasciitis of the perineum may lead to hospitalization, may require several surgeries to remove affected tissues, and may result in death. Seek immediate medical attention if you have a fever or if you feel very weak, tired or uncomfortable (malaise) and develop one of the following symptoms in the area between and around your anus and your bads: pain or tenderness, swelling or redness of the skin (erythema).
Serious allergic reaction. If you experience symptoms of a severe allergic reaction, stop taking INVOKANA.® and call your doctor immediately or go to the emergency room of the nearest hospital.
Broken bones (fractures): Bone fractures have been observed in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of fracture.
The most common side effects of INVOKANA® include: badl yeast infections and yeast infections of the penis; changes in urination, including the urgent need to urinate more often, in larger amounts or at night.
Tell your doctor if you have a side effect that bothers you or does not go away. Call your doctor for medical advice on side effects. You can report side effects to the FDA at 1-800-FDA-1088. You can also report adverse reactions to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please click here for complete Product Information, Including Boxed Warning, and Medication guide for INVOKANA®.
Canagliflozin is registered by Mitsubishi Tanabe Pharma Corporation.
Trademarks belong to their respective owners.
About Janssen Cardiovascular and Metabolism
In Cardiovascular & Metabolism (CVM), we fight the most prevalent diseases that afflict hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and driven by our successes in treating type 2 diabetes and thrombosis, we offer highly differentiated treatments that prevent and treat life-threatening cardiovascular, metabolic and retinal diseases. . Discovering new therapies that can improve the quality of life of this large segment of the population is an important undertaking – an activity that Janssen CVM will continue to pursue in the years to come. Our mission is global, local and personal. Together, we can redefine the future of prevention and treatment of cardiovascular, metabolic and retinal diseases. Please visit www.janssen.com/cardiovascular-and-metabolism.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we create a future where disease is a thing of the past. As Johnson & Johnson's pharmaceutical companies, we work tirelessly to make this future a reality for all patients by fighting disease through science, improving access through ingenuity and healing. despair with heart. We focus on the areas of medicine where we can make the biggest difference: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology and pulmonary hypertension.
Learn more at www.janssen.com. Follow us on www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Precautions regarding forward-looking statements
This press release contains "forward-looking statements" within the meaning of the Securities Industry Litigation Reform Act, 1995 Potential benefits and further development of canagliflozin. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If the underlying badumptions prove to be inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from the expectations and projections of Janssen Research & Development, LLC. other companies of Janssen Pharmaceutical and / or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and the receipt of approvals regulations; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents obtained by competitors; patent challenge; product effectiveness or safety issues resulting in product recalls or regulatory actions; behavioral changes and consumer habits of purchasers of health care products and services; changes in applicable laws and regulations, including global health care reforms; and trends toward cost control of health care. An additional list and description of these risks, uncertainties and other factors are available in the Johnson & Johnson Form 10-K Annual Report for the year ended December 30, 2018, including in the "Caution Regarding Forward-Looking Information" and "Section 1.A Risk Factors" sections, as well as in the Company's latest quarterly report on Form 10-Q and in subsequent Company filings filed with the Company. Securities and Exchange Commission. Copies of these documents are available online at www.sec.gov, www.jnj.com or upon request from Johnson & Johnson. None of the Janssen Pharmaceuticals nor Johnson & Johnson agrees to update the forward-looking statements as a result of new information or future events or developments.
I Dr. Vlado Perkovic worked directly with Janssen R & D and was paid for the CREDENCE study.
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SOURCE Janssen Pharmaceutical Companies from Johnson & Johnson
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