April 2, 2019 PR-M04-19-NI-008
RARITAN, N.J. /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking a new indication for INVOKANA®(canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), the doubling of serum creatinine, which is a key predictor of ESKD, and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). The submission is based on results from the Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study, which evaluated the efficacy and safety of INVOKANA® versus placebo in this high-risk patient population when used in addition to standard of care.
Primary investigators will present the CREDENCE data during a late-breaking clinical trials session at the International Society of Nephrology (ISN) World Congress of Nephrology (WCN) Annual Meeting in Melbourne, Australia on April 15 at 8:30 am AEST (April 14 at 6:30 pm EDT in the U.S.). An open access live-stream of the late-breaking presentation can be accessed here (registration is required).
"Today, millions of people living with type 2 diabetes and chronic kidney disease are at high risk of experiencing kidney failure, and unfortunately, we have not seen treatment innovation for these patients in almost 20 years. Janssen's application is a significant step toward bringing a much-needed, new standard of care for those living with these serious conditions," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "We look forward to presenting the CREDENCE data at the ISN World Congress of Nephrology and working closely with the FDA to bring this important medicine as quickly as possible to people living with type 2 diabetes and chronic kidney disease."
[Click to Tweet: #BREAKING @JanssenUS announces it has submitted a supplemental New Drug Application to the U.S. #FDA for its type 2 diabetes medicine. http://po.st/YWzJQq See full PI incl. Boxed Warning https://po.st/mQHTEl]
In July 2018, based upon an Independent Data Monitoring Committee meeting, the CREDENCE clinical trial stopped early because it met the pre-specified criteria for efficacy. If approved, INVOKANA® will be the first diabetes medicine for the treatment of people living with type 2 diabetes and chronic kidney disease.
About the CREDENCE Study
The Phase 3 CREDENCE clinical study is the first dedicated renal outcomes study of any sodium glucose co-transporter 2 (SGLT2) inhibitor in patients with T2D and CKD in addition to standard of care. The study is a randomized, double-blind, event-driven, placebo-controlled, parallel-group, 2-arm, multicenter study, which 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/ 1.73m2) and macroalbuminuria (defined as urinary albumin-to-creatinine ratio [ACR] >300 to ≤5000 mg/g), who were receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB).
At this time, INVOKANA® is contraindicated for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis. In addition, INVOKANA® is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2.
WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used:
IMPORTANT SAFETY INFORMATION
INVOKANA® can cause important side effects, including:
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKANA® if you:
Before you take INVOKANA®, tell your doctor if you have a history of amputation; heart disease or are at risk for heart disease; blocked or narrowed blood vessels (usually in leg); damage to the nerves (neuropathy) of your leg; diabetic foot ulcers or sores; kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA®; or have other medical conditions.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), 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® may cause serious side effects, including:
Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.
Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room.
Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture.
The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
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, and 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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding 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 underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.