FDA Issues Complete Response Letter for XARELTO® (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute

 FDA Issues Complete Response Letter for XARELTO® (rivaroxaban) to Reduce the
      Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome

PR Newswire

RARITAN, N.J., June 28, 2013

RARITAN, N.J., June 28, 2013 /PRNewswire/ --Janssen Research & Development,
LLC (Janssen) today announced the U.S. Food and Drug Administration (FDA) has
issued a complete response letter for the supplemental New Drug Application
(sNDA) for XARELTO^® (rivaroxaban) to reduce the risk of stent thrombosis in
patients with acute coronary syndrome (ACS).

"We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are
in ongoing discussions with the FDA regarding this sNDA," said Dr. Christopher
Nessel, Vice President, Cardiovascular Franchise Medical Leader at Janssen.

This sNDA is based on results from the 15,526-patient pivotal Phase 3 ATLAS
ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to
aspirin with/without thienopyridine therapy in Subjects with Acute Coronary
Syndrome) clinical trial of XARELTO^® which were presented at the American
Heart Association annual Scientific Sessions in November 2011 and
simultaneously published by the New England Journal of Medicine. Data from
the ATLAS ACS 2 TIMI 51 trial also support the separate sNDA for XARELTO^® to
reduce the risk of cardiovascular events in patients with ACS, for which
Janssen received a second complete response letter on March 4, 2013.

Coronary stents are implanted in more than 1.5 million patients each year.
Stent thrombosis occurs when blood pools at the site of an implanted stent
within a patient's coronary artery. Stent thrombosis is an uncommon, but
serious complication that can result in a heart attack or even death.

ACS is a complication of coronary heart disease, which is the leading cause of
death in the U.S. and one of the most prevalent non-communicable diseases in
the world. ACS occurs when a blood clot blocks a coronary artery, reducing
blood supply to the heart. This disruption of blood flow can cause a heart
attack, or unstable angina, a condition signifying that a heart attack may
soon occur. Each year, an estimated 1.2 million patients in the U.S. are
discharged from the hospital with a diagnosis of ACS.

XARELTO^® is the most prescribed novel oral anticoagulant in the U.S. market
today and is approved for six clinical uses in the U.S. It has earned the
strongest reimbursement profile among novel anticoagulants, with 85 percent of
patients on Medicare Part D and 85 percent of commercial patients covered at
the lowest branded co-pay. To date, more than 5 million patients have received
XARELTO^® worldwide and more than 2 million prescriptions have been written
for XARELTO^® in the U.S.

About XARELTO^® (rivaroxaban)
XARELTO^® works by blocking the blood clotting Factor Xa. XARELTO^® does not
require routine blood monitoring. XARELTO^® is the only Factor Xa inhibitor
approved for six distinct uses:

1.To reduce the risk of blood clots in the legs and lungs of people who have
    just had knee replacement surgery.
2.To reduce the risk of blood clots in the legs and lungs of people who have
    just had hip replacement surgery.
3.To reduce the risk of both hemorrhagic and thrombotic strokes as well as
    other blood clots in people with atrial fibrillation not caused by a heart
    valve problem. There is limited information on how XARELTO^® compares to a
    medicine called warfarin in reducing the risk of stroke when the effects
    of warfarin are well controlled.
4.To treat people with pulmonary embolism (PE).
5.To treat people with deep vein thrombosis (DVT).
6.To reduce the risk of recurrence of DVT or PE following an initial six
    months of treatment for acute venous thromboembolism.

The extensive program of clinical trials evaluating rivaroxaban makes the
compound the most studied oral, Factor Xa inhibitor in the world today. By the
time of its completion, more than 100,000 patients will have participated in
the rivaroxaban clinical development program.

Janssen Research & Development, LLC, and Bayer HealthCare together are
developing rivaroxaban.

For more information about XARELTO^®, ^ visit www.xarelto-us.com. The
XARELTO^® CarePath™ Support Program is a resource designed for healthcare
providers, patients and caregivers.Visit www.xareltocarepath.com or call
1-888-XARELTO to learn more about the XARELTO^® CarePath™ resources focused on
access, education and adherence.



  oFor people taking XARELTO^® for atrial fibrillation:

    People with atrial fibrillation (an irregular heart beat) are at an
    increased risk of forming a blood clot in the heart, which can travel to
    the brain, causing a stroke, or to other parts of the body. XARELTO^®
    lowers your chance of having a stroke by helping to prevent clots from
    forming. If you stop taking XARELTO^®, you may have increased risk of
    forming a clot in your blood.

    Do not stop taking XARELTO^® without talking to the doctor who prescribes
    it for you. Stopping XARELTO^® increases your risk of having a stroke.

    If you have to stop taking XARELTO^®, your doctor may prescribe another
    blood thinner medicine to prevent a blood clot from forming.
  oXARELTO^® can cause bleeding, which can be serious, and rarely may lead to
    death. This is because XARELTO^® is a blood thinner medicine that reduces
    blood clotting. While you take XARELTO^® you are likely to bruise more
    easily and it may take longer for bleeding to stop.

You may have a higher risk of bleeding if you take XARELTO^® and take other
medicines that increase your risk of bleeding, including:

  oAspirin or aspirin-containing products
  oNon-steroidal anti-inflammatory drugs (NSAIDs)
  oWarfarin sodium (Coumadin^®, Jantoven^®)
  oAny medicine that contains heparin
  oClopidogrel (Plavix^®)
  oOther medicines to prevent or treat blood clots

Tell your doctor if you take any of these medicines. Ask your doctor or
pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you develop any of these
signs or symptoms of bleeding:

  oUnexpected bleeding or bleeding that lasts a long time, such as:
  oNosebleeds that happen often
  oUnusual bleeding from gums
  oMenstrual bleeding that is heavier than normal, or vaginal bleeding
  oBleeding that is severe or that you cannot control
  oRed, pink, or brown urine
  oBright red or black stools (looks like tar)
  oCough up blood or blood clots
  oVomit blood or your vomit looks like "coffee grounds"
  oHeadaches, feeling dizzy or weak
  oPain, swelling, or new drainage at wound sites

Spinal or epidural blood clots (hematoma): People who take a blood thinner
medicine (anticoagulant) like XARELTO^®, and have medicine injected into their
spinal and epidural area, or have a spinal puncture, have a risk of forming a
blood clot that can cause long-term or permanent loss of the ability to move
(paralysis). Your risk of developing a spinal or epidural blood clot is higher

  oA thin tube called an epidural catheter is placed in your back to give you
    certain medicine
  oYou take NSAIDs or a medicine to prevent blood from clotting
  oYou have a history of difficult or repeated epidural or spinal punctures
  oYou have a history of problems with your spine or have had surgery on your

If you take XARELTO^® and receive spinal anesthesia or have a spinal puncture,
your doctor should watch you closely for symptoms of spinal or epidural blood
clots. Tell your doctor right away if you have tingling, numbness, or muscle
weakness, especially in your legs and feet.


Do not take XARELTO^® if you:

  oCurrently have certain types of abnormal bleeding. Talk to your doctor
    before taking XARELTO^® if you currently have unusual bleeding.
  oAre allergic to rivaroxaban or any of the ingredients of XARELTO^®.


Before taking XARELTO^®, tell your doctor if you:

  oHave ever had bleeding problems
  oHave liver or kidney problems
  oHave any other medical condition
  oAre pregnant or plan to become pregnant. It is not known if XARELTO^® will
    harm your unborn baby. Tell your doctor right away if you become pregnant
    while taking XARELTO^®. If you take XARELTO^® during pregnancy, tell your
    doctor right away if you have bleeding or symptoms of blood loss.
  oAre breastfeeding or plan to breastfeed. It is not known if XARELTO^®
    passes into your breast milk. You and your doctor should decide if you
    will take XARELTO^® or breastfeed.

Tell all of your doctors and dentists that you are taking XARELTO^®. They
should talk to the doctor who prescribed XARELTO^® for you before you have any
surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and
nonprescription medicines, vitamins, and herbal supplements. Some of your
other medicines may affect the way XARELTO^® works. Certain medicines may
increase your risk of bleeding. See "What is the most important information I
should know about XARELTO^®?"

Especially tell your doctor if you take:

  oKetoconazole (Nizoral^®)
  oItraconazole (Onmel^™, Sporanox^®)
  oRitonavir (Norvir^®)
  oLopinavir/ritonavir (Kaletra^®)
  oIndinavir (Crixivan^®)
  oCarbamazepine (Carbatrol^®, Equetro^®, Tegretol^®, Tegretol^®-XR, Teril^™,
  oPhenytoin (Dilantin-125^®, Dilantin^®)
  oPhenobarbital (Solfoton^™)
  oRifampin (Rifater^®, Rifamate^®, Rimactane^®, Rifadin^®)
  oSt. John's wort (Hypericum perforatum)

Ask your doctor if you are not sure if your medicine is one listed above. Know
the medicines you take. Keep a list of them to show your doctor and pharmacist
when you get a new medicine.


Take XARELTO^® exactly as prescribed by your doctor.

Do not change your dose or stop taking XARELTO^® unless your doctor tells you

  oYour doctor will tell you how much XARELTO^® to take and when to take it.
  oYour doctor may change your dose if needed.

If you take XARELTO^® for:

  oAtrial Fibrillation: Take XARELTO^® 1 time a day with your evening meal.
    If you miss a dose of XARELTO^®, take it as soon as you remember on the
    same day. Take your next dose at your regularly scheduled time.
  oBlood clots in the veins of your legs or lungs:

       oTake XARELTO^® once or twice a day as prescribed by your doctor.
       oTake XARELTO^® with food at the same time each day.
       oIf you miss a dose of XARELTO^®:

            +and take XARELTO^® 2 times a day: Take XARELTO^® as soon as you
              remember on the same day. You may take 2 doses at the same time
              to make up for the missed dose. Take your next dose at your
              regularly scheduled time.
            +and take XARELTO^® 1 time a day: Take XARELTO^® as soon as you
              remember on the same day. Take your next dose at your regularly
              scheduled time.

       oHip or knee replacement surgery: Take XARELTO^® 1 time a day with or
         without food. If you miss a dose of XARELTO^®, take it as soon as
         you remember on the same day. Take your next dose at your regularly
         scheduled time.

  oIf you have difficulty swallowing the tablet whole, talk to your doctor
    about other ways to take XARELTO^®.
  oYour doctor will decide how long you should take XARELTO^®. Do not stop
    taking XARELTO^® without talking to your doctor first.
  oYour doctor may stop XARELTO^® for a short time before any surgery,
    medical or dental procedure. Your doctor will tell you when to start
    taking XARELTO^® again after your surgery or procedure.
  oDo not run out of XARELTO^®. Refill your prescription for XARELTO^® before
    you run out. When leaving the hospital following a hip or knee
    replacement, be sure that you have XARELTO^® available to avoid missing
    any doses.
  oIf you take too much XARELTO^®, go to the nearest hospital emergency room
    or call your doctor right away.


Please see "What is the most important information I should know about

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 are also
encouraged to report side effects to the FDA: visit
http://www.fda.gov/medwatchor call 1-800-FDA-1088. You may also report side
effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please clickherefor full prescribing information,including Boxed
Warningsand theMedication Guide.

Trademarks are those of their respective owners.

About Janssen
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people
throughout the world. Janssen Research & Development, LLC and Janssen
Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of
Johnson & Johnson. Please visit http://www.janssenrnd.com for more

(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 Research &
Development, LLC 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 Research & Development, LLC nor Johnson &
Johnson undertake to update any forward-looking statements as a result of new
information or future events or developments.)


Kristina Chang
Tel: (908) 927-2416
Mobile: (201) 213-4115

Bill Foster
Tel: (908) 704-4404
Mobile: (908) 392-6057


Johnson & Johnson
Louise Mehrotra
Tel: (732) 524-6491

Johnson & Johnson
Stan Panasewicz
Tel: (732) 524-2524

SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com
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