MELBOURNE, Australia, April 14, 2019 / PRNewswire / – Johnson & Johnson's Janssen Pharmaceutical companies today released new results from Phase 3 CREDENCE study, which & # 39; show INVOKANA® (canagliflozin) shows a reduction of 30 percent in & # 39; a primary combined endpoint, consisting of progression to a posterior kidney force (ESDD), defined as the need for renal renal refinement type (RRT) such as chronic dialysis or renal transplant; Double serum creatinine, an ESDD test leader; and renal or cardiovascular (CV) death. The highlighted study evaluated the effectiveness and safety of INVOKANA® against placebo in patients with chronic kidney force (CKD) and type 2 diabetes (T2D) as used alongside the standard of care. Study results have also indicated INVOKANA® The risk of secondary CV endpoints expires, including the risk of CV death and hospitalization for 31% heart rate, major negative CV events (MACE; nonfatal myocardial infarction composite [MI], non-fatal stick and CV death by 20 percent, and the risk of heart disease failure only by 39 percent. Important is the study no insecurity in amputation or bonefracteur. In addition, no new safety tools were identified in the study of high-risk patients.
The data was presented today in a late class session at the International Society of Nephrology (ISN) 2019 World Congress of Nephrology (WCN) Melbourne, Australia, and simultaneously published in The New England Journal of Medicine.
"Canagliflozin is the first medical breakthrough in nearly twenty years proven to be the progression of a chronic kidney force in the diabetic patients at risk of developing kidney disease," Vlado Perkovicme, M.B.B.S, Ph.D., F.A.S.N., F.R.A.C.P., CREDENCE Steering Committee chair, director director, The George Institute for Global Health, Australia and professor of medicine, UNSW Sydney. "These impressive results from the CREDENCE study have important clinical implications for preventing kidney and health improvement for millions of people living with chronic kidney and type 2 diabetes."
"Diabetes is the major cause of kidney disease for millions of people in the world, and this clear need to enable a new treatment was the motivation for CREDENCE study initiation.® as the only medicine to minimize the risk of renal failure in these high-risk patient populations when added to current standard node, " James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "We are working closely with the External FDA and healthcare institutions worldwide to get these important medicines to live with these life-threatening conditions."
The phase 3 CREDENCE (Canagliflozin and Renal Ein vents Dsomething to do with it Estationed Nephropathy Clinear Eevaluation, NCT02065791) clinical trials were a randomized, double-blind, event, poster, parallel group, 2-arm, multi-center study. It evaluated 4,401 patients with T2D, Stage 2 or 3 CKD (defined as a certain glomerular filtrate (eGFR) of ≥30 to <90 mL / min /1.73 m2), and macroalbuminuria (defined as urine albumin-to-creatinine ratio (ACR)> 300 to .0005,000 mg / g), which is a standard care, including a maximally tolerated controlled temporal dose of angiotensin-converting enzyme ( ACE) inhibitors Angiotensin II receptor blockers (ARBs).
"By Janssen, we have a number of very challenging and hard-core centers of the world, by examining the ability of our established medicine to maintain unity and by preventing & A scales of science to develop completely new medicines, & # 39; Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "The Critical Critical CREDENCE results give us the effort to help patients, and bring us one step closer to treating some of the" 2 "type 2 diabetes findings. and the unmet needs of millions of people living with a chronic kidney. "
In March 2019, Janssen records CREDENCE data in the submission of an additional new drug application to the U.S. FDA for INVOKANA® to reduce the risk of ESDD, double serum creatinine, and renal or CV death for adults with CKD and T2D. This followed an independent database management survey July 2018, where it recommends the commission to take the CREDENCE issue strangely to meet the predictive efficiency criteria. If this new indication is approved, INVOKANA is® would be the first diabetes medication to treat both T2D and CKD and can incorporate an important new treatment for the millions of patients to live the world with this disease.
In the CREDENCE study, INVOCATE® has a 30 percent reduction in & nbsp; risk of & # 39; a primary composer endpoint – consisting of progression for serum secretion, 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 composer endpoint, as well as distinguishing all 15 pre-specified subgroups. INVOCATION® The risk of a posterior kidney disease was 32 percent (HR: 0.68; 95% CI: 0.54 to 0.86; p = 0.0015).
Furthermore, INVOKANA® has included a 20 percent reduction in & risk's risk of & # 39; the secondary endpoints of MACE, which consist of fatality MI, no fatal strokes, and CV death (HR: 0.80; 95% CI: 0.67 to 0.95 p = 0.0121), in 31 percent reduction in & # 39; a consequence of & # 39; a composition 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 heart failure in heart failure alone (HR: 0.61; 95% CI: 0.47 to 0.80; p = 0.0003).
The incidence rates of over-the-counter events and serious adversary events were lowered more for paths treated with INVOKANA® in comparison to a boat. There were no differences in treatment of amputations (HR: 1.11; 95% CI: 0.79 to 1.56) or judicial fractures (HR: 0.98; 95% CI: 0.70 to 1.37) .
Currently INVOKANA is®, which is currently indicated for the treatment of glycemia in patients with T2D and the reduction of MACE in patients with T2D and CV disease, has been rejected for patients with severe renal impairment (eGFR <30 mL / min /1.73 m2), ESKD, or patients on dialysis. In addition, INVOKANA® is not induced if eGFR is personally less than 45 mL / min /1.73 m2. Please see the important safety information and the full precision information for additional details.
Where is INVOKANA®?
INVOCATION® is a prescription medication used:
- in diets and busy lowering lower artery (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. INVOCATION® is not for people with type 1 diabetes or with diabetic ketoacidosis (elevated ketones in blood or urine). It is not known as INVOKANA® is safe and effective in children under 18 years of age.
INVOCATION® can cause important side effects, including:
- Amputations. INVOCATION® can increase your risk of army limb amputations. Amputations usually include removing the tea or part of a foot; However, amputations with the laying, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower amputation than you have: a history of amputation, their heart rate or having risks for heart strength, blocked or prolonged blood fats (usually in the army), have damage to & # 39; a nerve (neuropathy) in a lie, or if it has been diabetic or diabetic. Get away from your doctor if you have new pain or tenderness, any taste, ulcers, or foot or foot infections. Your doctor may decide to stop your INVOKANA® For a while if you have any of these signs or symptoms. Talk to your doctor about good foot care
- Dydydratation. INVOCATION® some people can be dried (the loss of too much body water), which can make you drowsy, heavy, light or weak, especially if you are infected (orthostatic hypotension). You may be at a higher risk of doubling when taking low-blood pressure medications to lower your blood pressure (like diuretics [water pills]), are on an empty sodium (salt) diet, have kidney problems, or are 65 years older or older
- Vaginal lifting infection. Women that & # 39; t take INVOKANA® can get all the infections. Symptoms include: vaginal odor, white or yellowish vaginal dislocation (may be a bell chime or seen as a housemaid), or vaginal jaundice
- Mostly infection of the penis (balanitis or balanoposthitis). Take People & # 39; INVOKANA® Make an update infection from & # 39; skin to & # 39; a penis. Symptoms include redness, joking, or swelling of a penis; arm of no pearl; foul-smelling emerges from & quot; purple & quot; or hurt in & nbsp; the skin for couple
Talk to your doctor about what to do if you get symptoms of a pyre or penis head infection.
Not INVOKANA® if you:
- are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may be: rash; Striking red patches on the skin (corners); or swelling of the face, lips, tongue and throat, which can cause problems in the atmosphere or sleep
- have severe kidney problems or are on dialysis
Before you take INVOKANA®, tell your doctor if you are have a history of amperage; force or risk of heart strength; blocked or prolonged blood fats (normal in lay); damage your leg's neuropathy; diabetic cats or wounds; Kidney problems; liverproblemen; history of urinary tract infections or urinary problems; are on an empty sodium (salt) diet; will have surgery; Know less because of illness, surgery or change in food; pancreatic problems; drink alcohol very often (or short term) a lot of alcohol; First, an allergic reaction to INVOKANA®; or have other medical conditions.
Tell your doctor if you are or plan to become pregnant, breastfeed, or plan to enjoy. INVOCATION® can damage unborn baby. If you become weak while taking INVOKANA®, tell your doctor away. INVOCATION® you can fit in your breast milk and skull your baby. Do not use allowed by INVOCANA®.
Tell your doctor about all medicines you take, including advertising and non-prescription medications, vitamins, and supplements. In particular, tell your doctor if your diuretic (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control controls), ritonavir (Norvir®, Kaletra® – used to treat HIV infection, or digoxin (Lanoxin®– used to treat heart problems).
Possible side effects of INVOKANA®
INVOCATION® can cause severe side effects, including:
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has occurred in people who have type 1 or type 2 diabetes, in dealing with INVOKANA®. Ketoacidosis is a serious condition that should not be treated in a hospital. Ketoacidosis can lead to death. Ketoacidosis can occur with INVOKANA® even if your blood sucker is less than 250 mg / dL. Stop INVOCANA® and your doctor immediately states if you get any of the following symptoms: abuse, lack, stomach ache, middle, or trouble
- Kidney problems. Many crashes have occurred on people taking the INVOKANA®. Talk to your doctor away if you: 1) how much it is or eat or whisper you drink, if you are ill, or cannot or can eat 2) start to eat away from your body fluid, diarrhea, or in the sun too long
- A high potassium in your blood (hyperkalemia)
- Serious Urine Tract Infections: can lead to hospitalization and have occurred in people taking the INVOKANA®. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as: the burning of feeling in the urination, often or immediately, pain in the stomach of your stomach (pelvis), or blood in your body. urine. Some people may also have high cycling, walking, lacking or lacking
- Hypoglycemia. If you take INVOKANA® With another drug that can cause frequent blood suckers, such as a sulphonyl or ensulin, you are at risk for low blood sugar. The dose of your sulphonylurea cured or inhaled should be necessary if you take INVOKANA®
Signs and symptoms of low-blue sugar may be: head vision, dryness, weakness, dizziness, distraction, travelers, hunger, rapid heart management, sweating, shaking, or sensitivity.
- A rare but serious bacterial infection that disturbs the conscience of the skin (necrotizing fasciitis) in the area between and around & # 39; e anus and genitals (perineum). Necrotising perineum fasciitis has occurred in women and men taking & nbsp; INVOCANA®. Necrotizing fasciitis from the perineum can lead to hospitalization, possibly requiring surgery to remove the affected tissue, and can lead to death. Seek medical attention immediately if you are sick or your feeling is weak, tender, or uncomfortable (malaise) and you develop one of the following symptoms in the area and your anus and genitals: pain or soreness, swelling, or reason of erythema.
Serious allergic reaction. If you do not have any symptoms of a serious allergic reaction, stop inserting® and direct your doctor away or go to the closest hospital.
Broken Bones: Button fractures can be seen in patients taking the INVOKANA®. Talk to your doctor about factors that can prevent your risk.
The most common side effects of INVOKANA® Including: vaginal grasp infections and animal findings of a penis; Urinary changes, including urgent need to worsen more often, in larger amounts, or in the night.
Tell your doctor if you have a page effect that you & # 39; t support or do not leave. Steal 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 side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Click here for full product information, Among others Boxed Warning, and Medical guide for INVOKANA®.
Canagliflozin is a loan from Mitsubishi Tanabe Pharma Corporation.
Trade names are those of their respective owners.
About Janssen Cardiovascular & Metabolism
In cardiovascular and metabolism (CVM), we are taking the most pervasive illness that it carries hundreds of millions of people and healthcare systems around the world. As part of this longest effort and through our success in treating type 2 diabetes (T2D) and thrombosis, we continue to perform very differentiated therapies that prevent it from being endangered cardiovascular, metabolic and retinal. Including new therapies that can improve the livelihood of this large segment of the population is an important direction – one that & # 39; t teach Janssen CVM in & # 39; in the coming years. Our mission is global, local and personal. Together we can change the future of cardiovascular, metabolic and retinal disability and treatment. Visit www.janssen.com/cardiovascular- and metabolism.
About the Janssen Pharmaceutical Companies by Johnson & Johnson
At Janssen we create a future there the disease is a thing of the past. We are the Pharmaceutical companies of Johnson & Johnson, the company without intent to make this future a reality for patients everywhere by consequence of illness with science, improving access to pleasure, and healing healing health with heart. We focus on areas of medicine where we can make the most difference: cardiovascular and metabolism, immunology, infection and diseases, vacuums, neurology, oncology and pulmonary hypertension.
Read more at www.janssen.com. Follow us www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is one of Johnson & Johnson's Janssen Pharmaceutical Companies.
Exercises regarding outgoing expenditure
This press release contains "progress" as defined in the 1995 Private Securities Litigation Reform Act potential benefits and further development of canagliflozin. The reader is not expected to earn on this occurring statement. These statements are based on current expectations of future events. If negotiating assets prove that unreachable or known or unknown risks realize uncertainties or uncertainties, the realizing results can guide material expectations of Janssen Research & Development, LLC's expectations and projections, one of & # 39; Other Janssen Pharmaceutical Companies, and / or Johnson & Johnson. Risk issues and uncertainties include, but are not limited to: challenges and ignorance of product research and development, including the uncertainty of clinical success and regulatory licensing; uncertainty of commercial success; production problems and losses; competition, including technical licenses, new products and patents that are reached; Herausforderungen für Patente; product efficiency or security policy that results in product or regulatory action; changes in the behavioral and representation of purchasers of healthcare products and services; Changes to applicable laws and regulations, including global healthcare reforms; and include trends in healthcare costs. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report for Form 10-K for the fishing lure December 30, 2018, among other things in the "Cautionary Note at a Distributed Declaration" chapter and "Item 1A Risk Factors", and in the company the most recent required quarterly report on Form 10-Q, and the following agreements on the company with the Securities and Exchange Commission. Copies of these departments can be viewed online at www.sec.gov, www.jnj.com or by Johnson & Johnson. Neither of Janssen Pharmaceutical Companies nor Johnson & Johnson signed up to update an up-to-date task as a result of new information or future events or developments.
me Dr. Vlado Perkovic worked director with Janssen R&D and was compensated for his work at CREDENCE study.
Jessica Castles Smith
SOURCE Janssen Pharmaceutical companies of Johnson & Johnson