`(Canagliflozin) for the Treatment of Adults
`with Type 2 Diabetes
`INVOKANA™ is the first in a new class of type 2 diabetes medications available in
`the United States
`In Phase 3 studies, INVOKANA™ improved blood glucose control and was
`associated with reductions in body weight and systolic blood pressure
`Janssen will partner with other Johnson & Johnson companies focused on diabetes
`to bring INVOKANA™ to healthcare professionals
`
`NEWS PROVIDED BY
`Janssen Pharmaceuticals, Inc.
`29 Mar, 2013, 04:37 ET
`
`
`
`RARITAN, N.J., March 29, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced
`today the U.S. Food and Drug Administration (FDA) has approved INVOKANA™ (canagliflozin)
`for the treatment of adults with type 2 diabetes. INVOKANA™ is the first in a new class of
`medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the
`United States. It is also the only oral, once-daily medication available in the United States
`offering improved glycemic control while also showing reduced body weight and
`systolic blood pressure in clinical trials.
`
`To view the multimedia content, please click here:
`http://www.multivu.com/players/English/60562-janssen-invokana
`
`"Patients with type 2 diabetes struggle managing their blood sugar, and nearly half of adults
`with type 2 diabetes do not achieve recommended levels of glucose control, increasing their
`risks for potentially life-threatening complications," said Richard Aguilar*, M.D., Medical
`Director, Diabetes Nation, LLC and Diabetes Care Foundation, a non-profit organization
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`committed to improving diabetes care. "INVOKANA™ is thought to work differently than
`other currently-available medicines because it reduces blood glucose by acting on the
`kidneys as a 'glucuretic,' increasing the loss of glucose in the urine. What has historically been
`viewed as a sign of diabetes – glucose in the urine – may also reflect the efficacy of a new and
`unique approach to treatment."
`
`The kidneys make an important contribution to balancing blood glucose. As glucose is
`filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An
`important carrier responsible for this reabsorption is called sodium glucose co-transporter 2
`(SGLT2). INVOKANA™ selectively inhibits SGLT2, and as a result promotes the loss of glucose
`in the urine, lowering blood glucose levels in adults with type 2 diabetes.
`
`"INVOKANA™ provides patients with type 2 diabetes the option of a once-daily oral therapy
`that offers improved glycemic control and, in Phase 3 studies, showed an incidence of
`hypoglycemia – low blood glucose – that was lower than with glimepiride and similar to that
`of sitagliptin," said Jimmy Ren, Ph.D., Therapeutic Area Lead, Metabolics, Medical Affairs,
`Janssen Pharmaceuticals, Inc. "In addition, this new treatment option is associated with
`reductions in body weight and systolic blood pressure."
`
`INVOKANA™ is indicated as an adjunct to diet and exercise to improve glycemic control in
`adults with type 2 diabetes. INVOKANA™ has been studied as a single agent (monotherapy),
`in combination with metformin, and in combination with other glucose-lowering agents,
`including insulin, in patients who need further glucose control. Results from the Phase 3
`studies showed INVOKANA™ was generally well tolerated. The most common adverse events
`with INVOKANA™ are genital mycotic (fungal) infections, urinary tract infections, and
`increased urination. These specific adverse events were generally mild to moderate in
`intensity and infrequently led to discontinuation in Phase 3 studies. Overall the rate of
`discontinuation due to adverse events was 4.3 percent for the INVOKANA™ starting dose of
`100 milligrams (mg), 3.6 percent for INVOKANA™ 300 mg and 3.1 percent versus competitors.
`
`INVOKANA™ is an important addition to the comprehensive platform of offerings for patients
`with diabetes from the Johnson & Johnson Family of Companies. Janssen will partner with
`other Johnson & Johnson companies focused on diabetes, such as LifeScan, Inc., and Animas
`
`
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`Corporation, to bring INVOKANA™ to healthcare professionals treating patients with
`diabetes.
`
`Janssen also will offer a dedicated INVOKANA™ CarePath support program to patients and
`caregivers. The program provides important support and information regarding affordable
`access, adherence and education, thereby helping patients to start and appropriately
`manage their disease and therapy over time.
`
`"We are delighted with the approval of INVOKANA™ because it provides a much-needed,
`new treatment option to help adults with type 2 diabetes and their physicians manage this
`disease," said Kirk Ways, M.D., Ph.D., Development Head, Cardiovascular & Metabolism and
`Compound Development Team Leader, Canagliflozin, Janssen Research & Development.
`
`The new drug application for INVOKANA™ was based on a comprehensive global Phase 3
`clinical program, which enrolled 10,285 patients in nine studies and is one of the largest
`clinical programs in type 2 diabetes submitted to health authorities to date.
`
`Results from this program showed that the 100 mg and the 300 mg doses of INVOKANA™
`improved glycemic control and, in prespecified secondary endpoints, were associated with
`significant reductions in body weight and systolic blood pressure. In two studies comparing
`INVOKANA™ to current standard treatments – one studying sitagliptin and the other
`studying glimepiride – INVOKANA™ dosed at 300 mg provided greater reductions in A1C
`levels and body weight than either comparator. A1C is the percent of red blood cell
`hemoglobin with glucose attached to it and an indicator of average blood glucose over the
`previous two to three months. In the two studies, the overall incidence of adverse events was
`similar with INVOKANA™ and the comparators.
`
`In studies of INVOKANA™ as monotherapy or in combination with agents not associated with
`hypoglycemia (such as metformin or metformin and pioglitazone), the incidence of
`hypoglycemic episodes were less than 5 percent across the groups (INVOKANA™ 100 mg [3.8
`percent], INVOKANA™ 300 mg [4.3 percent], and placebo [2.2 percent]). There have been no
`clinical studies establishing conclusive evidence of macrovascular risk reduction with
`INVOKANA™ or any other antidiabetic medication. Additional data are being collected to
`further characterize the cardiovascular profile of INVOKANA™.
`
`
`
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`The Phase 3 studies for INVOKANA™ were presented at the American Diabetes Association
`(ADA) Annual Scientific Sessions in June 2012, at the European Association for the Study of
`Diabetes (EASD) Annual Meeting in October 2012, and at the World Congress on
`Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in November
`2012.
`
`Janssen and its affiliates have rights to INVOKANA™ through a license agreement with
`Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have
`marketing rights in North America, South America, Europe, the Middle East, Africa, Australia,
`New Zealand, and parts of Asia.
`
`About Type 2 Diabetes
`
`The U.S. Centers for Disease Control and Prevention estimates that nearly 26 million
`Americans have diabetes, 90 to 95 percent of which is type 2 diabetes. Type 2 diabetes is a
`chronic condition that affects the body's ability to metabolize sugar, or glucose, and is
`characterized by the inability of pancreatic beta cell function to keep up with the body's
`demand for insulin. U.S. national data from 2007 to 2010 show that nearly half of adults with
`1
`type 2 diabetes were not achieving recommended levels of glucose control.
`2
`
`Approximately 60 percent of patients with type 2 diabetes in the United States are obese,
`while another 30 percent are overweight. In most people at risk for type 2 diabetes, obesity
`causes the body to resist the action of insulin, and if the pancreatic beta cell cannot produce
`enough insulin, hyperglycemia and type 2 diabetes ensue. If left uncontrolled, type 2 diabetes
`can lead to serious complications; improved glycemic control has been demonstrated to
`reduce the onset and progression of these complications.
`1
`
`INDICATION STATEMENT
`
`WHAT IS INVOKANA™?
`
`
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`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.
`INVOKANA™ is not for people 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
`
`WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT INVOKANA™?
`INVOKANA™ can cause important side effects, including:
`
`Dehydration. INVOKANA™ can cause some people to have dehydration (the loss of body
`water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak,
`especially when you stand up (orthostatic hypotension).
`
`You may be at higher risk of dehydration if you:
`
`
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`have low blood pressure
`take medicines to lower your blood pressure, including diuretics (water pill)
`are on low sodium (salt) diet
`have kidney problems
`are 65 years of age or older
`Vaginal yeast infection. Women who take INVOKANA™ may get vaginal yeast infections.
`Symptoms of a vaginal yeast infection include:
`vaginal odor
`white or yellowish vaginal discharge (discharge may be lumpy or look like cottage
`cheese)
`vaginal itching
`Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA™
`may get a yeast infection of the skin around the penis. Certain men who are not
`circumcised may have swelling of the penis that makes it difficult to pull back the skin
`around the tip of the penis. Other symptoms of yeast infection of the penis include:
`redness, itching, or swelling of the penis
`rash of the penis
`foul smelling discharge from the penis
`pain in the skin around penis
`
`Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or
`penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to
`your doctor right away if you use an over-the-counter antifungal medication and your
`symptoms do not go away.
`
`WHO SHOULD NOT TAKE INVOKANA™?
`Do not take INVOKANA™ if you:
`
`
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`are allergic to canagliflozin or any of the ingredients in INVOKANA™. See the end of the
`Medication Guide for a list of ingredients in INVOKANA™. Symptoms of allergic reaction
`to INVOKANA™ may include:
`rash
`raised red patches on your skin (hives)
`swelling of the face, lips, tongue, and throat that may cause difficulty in breathing
`or swallowing
`have severe kidney problems or are on dialysis
`
`WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING INVOKANA™?
`Before you take INVOKANA™, tell your doctor if you:
`
`have kidney problems
`have liver problems
`are on a low sodium (salt) diet. Your doctor may change your diet or your dose of
`INVOKANA™.
`have ever had an allergic reaction to INVOKANA™
`have other medical conditions
`are pregnant or plan to become pregnant. It is not known if INVOKANA™ will harm your
`unborn baby. If you are pregnant, talk with your doctor about the best way to control
`your blood sugar while you are pregnant.
`are breastfeeding or plan to breastfeed. It is not known if INVOKANA™ passes into your
`breast milk. Talk with your doctor about the best way to feed your baby if you are taking
`INVOKANA™.
`
`Tell your doctor about all the medicines you take, including prescription and non-
`prescription medicines, vitamins, and herbal supplements.
`
`INVOKANA™ may affect the way other medicines work, and other medicines may affect how
`INVOKANA™ works. Especially tell your doctor if you take:
`
`
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`diuretics (water pills)
`rifampin (used to treat or prevent tuberculosis)
`phenytoin or phenobarbital (used to control seizures)
`ritonavir (Norvir®, Kaletra®, Lopinavir ®)* (used to treat HIV infection)
`
`digoxin (Lanoxin®)* (used to treat heart problems)
`
`Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine
`is listed above.
`
`Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist
`when you get a new medicine.
`
`HOW SHOULD I TAKE INVOKANA™?
`
`
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`Take INVOKANA™ by mouth 1 time each day exactly as your doctor tells you to take it.
`Your doctor will tell you how much INVOKANA™ to take and when to take it. Your doctor
`may change your dose if needed.
`It is best to take INVOKANA™ before the first meal of the day.
`Your doctor may tell you to take INVOKANA™ along with other diabetes medicines. Low
`blood sugar can happen more often when INVOKANA™ is taken with certain other
`diabetes medicines. See "What are the possible side effects of INVOKANA™?"
`If you miss a dose, take it as soon as you remember. If it is almost time for your next dose,
`skip the missed dose and take the medicine at the next regularly scheduled time. Do
`not take two doses of INVOKANA™ at the same time. Talk to your doctor if you have
`questions about a missed dose.
`If you take too much INVOKANA™, call your doctor or go to the nearest hospital
`emergency room right away. When your body is under some types of stress, such as
`fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes
`medicine you need may change. Tell your doctor right away if you have any of these
`conditions and follow your doctor's instructions.
`Stay on your prescribed diet and exercise program while taking INVOKANA™.
`Check your blood sugar as your doctor tells you to.
`INVOKANA™ will cause your urine to test positive for glucose.
`Your doctor may do certain blood tests before you start INVOKANA™ and during
`treatment as needed. Your doctor may change your dose of INVOKANA™ based on the
`results of your blood tests.
`Your doctor will check your diabetes with regular blood tests, including your blood sugar
`levels and your hemoglobin A1C.
`
`WHAT ARE THE POSSIBLE SIDE EFFECTS OF INVOKANA™?
`INVOKANA™ may cause serious side effects, including:
`See "What is the most important information I should know about INVOKANA™?"
`
`
`
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`kidney problems
`a high amount of potassium in your blood (hyperkalemia)
`low blood sugar (hypoglycemia). If you take INVOKANA™ with another medicine that
`can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low
`blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be
`lowered while you take INVOKANA™.
`
`Signs and symptoms of low blood sugar may include:
`
`headache
`drowsiness
`weakness
`dizziness
`confusion
`irritability
`hunger
`fast heart-beat
`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. See "Who should not take INVOKANA™?". Your doctor may give you a
`medicine for your allergic reaction and prescribe a different medicine for your diabetes.
`
`The most common side effects of INVOKANA™ include:
`
`vaginal yeast infections and yeast infections of the penis (See "What is the most
`important information I should know about INVOKANA™?")
`urinary tract infection
`changes in urination, including urgent need to urinate more often, in larger amounts, or
`at night
`
`
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`Tell your doctor if you have any side effect that bothers you or that does not go away. These
`are not all the possible side effects of INVOKANA™. For more information, ask your doctor or
`pharmacist.
`
`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 Prescribing Information and Medication Guide.
`
`Trademarks are those of their respective owners.
`
`K02CAN13050
`
`About Janssen Pharmaceuticals, Inc.
`As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen
`Pharmaceuticals, Inc. is dedicated to addressing and resolving the major unmet medical
`needs of our time. Driven by our commitment to patients, healthcare professionals, and
`caregivers, we strive to develop sustainable and integrated healthcare solutions by working in
`partnership with all stakeholders on the basis of trust and transparency. Our daily work is
`guided by meeting goals of excellence in quality, innovation, safety, and efficacy in order to
`advance patient care.
`
`Our company provides medicines for an array of illnesses and disorders in several therapeutic
`areas. Other innovative therapies that Janssen Pharmaceuticals, Inc. offers include ACIPHEX
`®
`(rabeprazole sodium), ELMIRON (pentosan polysulfate sodium), INVEGA SUSTENNA
`®
`®
`®
`(paliperidone palmitate) extended-release injectable suspension, NUCYNTA ER (tapentadol
`®
`extended-release tablets), RISPERDAL CONSTA (risperidone) Long-Acting Injection and
`®
`®
`XARELTO (rivaroxaban). The full prescribing information for INVEGA SUSTENNA ,
`®
`®
`®
`NUCYNTA ER and RISPERDAL CONSTA and XARELTO , including boxed warnings, are
`®
`®
`®
`®
`available here, here, here, and here.
`
`
`
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`For more information on Janssen Pharmaceuticals, Inc., visit us at
`www.janssenpharmaceuticalsinc.com or follow us on Twitter at www.twitter.com/JanssenUS
`and on YouTube at www.Youtube.com/JanssenUS.
`
`This press release contains "forward-looking statements" as defined in the Private Securities
`Litigation Reform Act of 1995. 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 unknown risks or uncertainties materialize,
`actual results could vary materially from the expectations and projections of Janssen
`Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are
`not limited to, general industry conditions and competition; economic factors, such as
`interest rate and currency exchange rate fluctuations; technological advances, new
`products and patents attained by competitors; challenges inherent in new product
`development, including obtaining regulatory approvals; challenges to patents; changes in
`behavior and spending patterns or financial distress of purchasers of health care products
`and services; changes to governmental laws and regulations and domestic and foreign
`health care reforms; trends toward health care cost containment; and increased scrutiny of
`the health care industry by government agencies. A further list and description of these
`risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's
`Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this
`Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com
`or on request from Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson
`& Johnson undertake to update any forward-looking statements as a result of new
`information or future events or developments.
`
`*Dr. Aguilar was not associated with the INVOKANA™ clinical trials and was not
`compensated for any media work. He has been a paid consultant to Janssen
`Pharmaceuticals, Inc.
`
`References
`
`1
`
`Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates
`and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA:
`U.S. Department of Health and Human Services, Centers for Disease Control and Prevention,
`
`
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`2011. Available at: http://www.diabetes.org/in-my-community/local-of ces/miami-
` orida/assets/ les/national-diabetes-fact-sheet.pdf. Accessed January 28, 2013.
` Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C,
`2
`blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care. 2013
`Feb 15. Epub ahead of print.
`
`SOURCE Janssen Pharmaceuticals, Inc.
`
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