RARITAN, N.J., June 6, 2016 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen), today announced that 18
"We look forward to sharing these robust scientific findings with healthcare providers and researchers at the American Diabetes Association's Scientific Sessions," said Paul Burton, M.D., Ph.D., Vice President, Medical Affairs, Janssen. "These studies and analyses build on the efficacy and safety findings from the pivotal trials that informed the approval of INVOKANA® for the treatment of type 2 diabetes and further our efforts to assess its potential benefits in patient populations who may benefit from this important medicine."
INVOKANA® is used along with diet and exercise to lower blood glucose in adults with type 2 diabetes. INVOKANA® is the number-one prescribed treatment in the newest class of medications called sodium glucose co?transporter 2 (SGLT2) inhibitors, which work with the kidneys to lower A1C. INVOKANA® is not indicated for weight loss or as antihypertensive treatment.
The abstracts for INVOKANA® data accepted for presentation at the American Diabetes Association's 76th Scientific Sessions are as follows:
Saturday, June 11, 2016
Clinical DataOral Abstract Session: 8:00-10:00 a.m.
Moderated Poster Discussion: 12:30-1:30 p.m.
Real-World EvidenceModerated Poster Discussion: 12:30-1:30 p.m.
Sunday, June 12, 2016
Clinical DataGeneral Poster Session: 12:00-2:00 p.m.
Patient-Reported OutcomesGeneral Poster Session: 12:00-2:00 p.m.
Real-World EvidenceGeneral Poster Session: 12:00-2:00 p.m.
Other Health Economics & Outcomes ResearchGeneral Poster Session: 12:00-2:00 p.m.
Monday, June 13, 2016
Clinical DataOral Abstract Session: 8:00-10:00 a.m.
Abstracts of all accepted presentations can be accessed on the American Diabetes Association's Scientific Sessions website.
About INVOKANA® In March 2013, the FDA approved canagliflozin – INVOKANA® – as a single agent. In two studies comparing INVOKANA® plus metformin to current standard treatments plus metformin – one studying sitagliptin1 and the other studying glimepiride2 – INVOKANA® dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. In the two studies, the overall incidence of adverse events was similar with INVOKANA® and the comparators. INVOKANA® is currently the number-one branded non-insulin type 2 diabetes medication prescribed by U.S. endocrinologists.3 It is also the second most common branded therapy prescribed by primary care physicians when adding or switching therapies in patients.4 Since its launch, more than 8 million prescriptions have been written for INVOKANA®.5
Janssen Pharmaceuticals, Inc., and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in Africa, parts of Asia, Australia, Europe, the Middle East, New Zealand, North America and South America.
INVOKANA® is approved as a single agent in Aruba, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, El Salvador, the European Union (28 countries), Guatemala, Hong Kong, Iceland, India, Israel, Jamaica, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Mexico, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Qatar, Russia, Serbia, Singapore, South Korea, Switzerland, Thailand, United Arab Emirates and the United States.
About Type 2 DiabetesOf the approximately 29 million people who have diabetes in the United States, 90 to 95 percent of them have type 2 diabetes, which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin.
WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. 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.
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 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.
Please see full Product Information and Medication Guide.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
About the Janssen Pharmaceutical CompaniesAt the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenUS.
1 Lavalle-Gonzalez F, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013 Dec;56(12):2582-92.
2 Cefalu T, Leiter L, Yoon K-H, Arias P, Niskanen L, Xie J, Balis D, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50.
3 Data on file. Based on NBRx data sourced from IMS NPA Market Dynamics Database, weekly data, showing INVOKANA® has been the leading branded non-insulin type 2 diabetes medication newly prescribed by U.S. endocrinologists for thirty one weeks, through January 2, 2015, the most recent data available at time of approval of INVOKAMET®.
4 Data on file. Based on NBRx data sourced from IMS NPA Market Dynamics Database, weekly data through January 2, 2015.
5 Data on file. Janssen Pharmaceuticals, Inc. Based on IMS Health, NPA Weekly, Total Prescriptions, April 2013- April 8th 2016.
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SOURCE Janssen Pharmaceuticals, Inc.
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