|Janssen to Present Data from Nine Abstracts on INVOKANA® (canagliflozin) at 2016 European Association for the Study of Diabetes Annual Meeting|
|By PR Newswire: Biotechnology|
|Friday, 09 September 2016 01:30|
RARITAN, N.J., Sept. 9, 2016 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced that nine presentations on INVOKANA® (canagliflozin) will be featured at the 2016 European Association for the Study of Diabetes (EASD) Annual Meeting, September 12-16 in Munich, Germany. Presentation topics include:
"We look forward to sharing these scientific findings with healthcare providers and researchers at the EASD annual meeting," said James F. List, M.D., Ph.D., Global Therapeutic Head, Cardiovascular & Metabolism, Janssen. "These data are encouraging as we continue to grow our understanding of the clinical impact of INVOKANA® and explore its potential benefits in broader patient populations."
These data were also presented at the 76th Scientific Sessions of the American Diabetes Association (ADA), June 10-14, 2016.
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 2016 European Association for the Study of Diabetes (EASD) Annual Meeting are as follows:
Tuesday, September 13, 2016
Poster Session 062 – SGLT-2 Inhibitors: Efficacy and Safety: 1:15-2:15 p.m.
Real World Evidence
Wednesday, September 14, 2016
Poster Session 064 – SGLT-2 Inhibitors: Clinical Trials: 1:15-2:15 p.m.
Real World Evidence De Novo
Thursday, September 15, 2016
Poster Session 065 – SGLT-2 Inhibitors: Pathophysiology:12:00-1:00 p.m.
Abstracts of all accepted presentations can be accessed on the European Association for the Study of Diabetes website.
In March 2013, the U.S. FDA approved canagliflozin – INVOKANA®– as a single agent. In two studies comparing INVOKANA® plus metformin to current standard treatments plus metformin – one studying sitagliptin[i] and the other studying glimepiride[ii] – 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.[iii] It is also the second most common branded therapy prescribed by primary care physicians when adding or switching therapies in patients.[iv] Since its launch, more than 8 million prescriptions have been written for INVOKANA®.[v]
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 Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Paraguay, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Korea, Thailand, Ukraine, United Arab Emirates, United Kingdom, and the United States.
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 youhave 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 youare 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.
At 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 www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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, LLCand/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description 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 January 3, 2016, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online atwww.sec.gov,www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
i 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.
ii 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.
iii 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®.
iv Data on file. Based on NBRx data sourced from IMS NPA Market Dynamics Database, weekly data through January 2, 2015.
v Data on file. Janssen Pharmaceuticals, Inc. Based on IMS Health, NPA Weekly, Total Prescriptions, April 2013- April 8th 2016.
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