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    Novartis announces Aliskiren will continue to be available to appropriate patients, as FDA interim assessment is concluded; product information updated

    Nachrichtenquelle: GlobeNewswire
     |  19.04.2012, 22:16  |  581  |  0

    Novartis International AG /
    Novartis announces Aliskiren will continue to be available to appropriate
    patients, as FDA interim assessment is concluded; product information updated
    . Processed and transmitted by Thomson Reuters ONE.
    The issuer is solely responsible for the content of this announcement.

    * Combination product Valturna® to be voluntarily withdrawn from the US market
    as of July 20, 2012

    Basel, Switzerland April 19, 2012 - Novartis announced today that the
    Tekturna(®) labels have been updated in the US, following the US Food and Drug
    Administration´s (FDA) review of the preliminary findings from the ALTITUDE

    The label change includes a contraindication against combined use of aliskiren-
    based products with angiotensin converting enzyme (ACE) inhibitors or
    angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also
    requested the inclusion of a warning against the use of aliskiren-based products
    in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are
    also taking an ACE inhibitor or an ARB. Aliskiren-based products will continue
    to be available in the US for the treatment of high blood pressure in
    appropriate patients.

    Furthermore, and in consultation with the FDA, Novartis has decided to
    voluntarily cease marketing in the US of Valturna(®) (aliskiren and valsartan,
    USP), a single pill combination of aliskiren and the ARB valsartan. Valturna
    sales in the US represented less than 10% of Aliskiren sales in 2011. Novartis
    advises US patients to seek guidance from their prescribing healthcare provider
    at their next (non-urgent) visit to determine appropriate alternate therapy.
    Novartis has also decided to voluntarily withdraw marketing authorization of the
    same combination pill in Switzerland, Rasival(® )(aliskiren and valsartan),
    which received marketing approval for export but was not launched.

    "These decisions come after extensive discussions with the FDA and Swissmedic, "
    said David Epstein, Division Head of Novartis Pharmaceuticals. "Patient safety
    continues to be our highest priority and we will continue to work with health
    authorities worldwide to provide aliskiren-based products to the most
    appropriate patient population who would benefit."

    These updates follow the Novartis announcement on February 17, 2012 that the
    European Medicines Agency´s (EMA) Committee for Medicinal Products for Human Use
    (CHMP) concluded the risk-benefit review of Rasilez and combination products
    containing aliskiren and confirmed it remains positive in the European Union
    (EU) for the treatment of essential hypertension, with label changes.

    About Aliskiren-based products in the US
    The US Prescribing Information has been updated for Tekturna, Tekturna HCT(®)
    (aliskiren and hydrochlorothiazide), Tekamlo(TM) (aliskiren and amlodipine) and
    Amturnide(TM) (aliskiren, amlodipine and hydrochlorothiazide).

     In view of the importance of controlling high blood pressure and to enable
    physicians to transition patients to alternate therapies, Novartis will make
    Valturna available in the US until July 20, 2012. Novartis advises patients in
    the US to seek guidance from their prescribing healthcare provider at their next
    (non-urgent) visit, prior to July 20, 2012, to determine appropriate alternate
    therapy. Novartis will communicate to US physicians informing them of the above

    About ALTITUDE
    ALTITUDE was a multinational study in 8,606 patients from 36 countries
    evaluating the potential benefits of aliskiren to reduce the risk of
    cardiovascular and renal events in this patient population.

    ALTITUDE was the first randomized, double-blind, placebo-controlled study to
    investigate aliskiren for more than one year in a specific population of
    patients with type 2 diabetes and renal impairment. These patients are known to
    be at high risk of cardiovascular and renal events. In the study, aliskiren was
    given in addition to optimal cardiovascular treatment including an angiotensin
    converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).

    About Aliskiren
    Aliskiren was approved in the US and EU in 2007 under the brand names Tekturna
    and Rasilez, respectively, for the treatment of hypertension either as
    monotherapy or in combination with other medications. It is available in 63
    countries. These products remain available for appropriate patients. For
    additional information, please visit

    US Important Safety Information

    TEKTURNA, TEKTURNA HCT, TEKAMLO, and AMTURNIDE are indicated for the treatment
    of hypertension in adults, to lower blood pressure. Lowering blood pressure
    reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes
    and myocardial infarctions. Control of high blood pressure should be part of
    comprehensive cardiovascular risk management, including, as appropriate, lipid
    control, diabetes management, antithrombotic therapy, smoking cessation,
    exercise, and limited sodium intake. Many patients will require more than one
    drug to achieve blood pressure goals.

    AMTURNIDE is not indicated for initial therapy of hypertension

    Use TEKTURNA HCT or TEKAMLO as initial therapy in patients who are likely to
    need multiple drugs to achieve their blood pressure goals. Switch a patient
    whose blood pressure is not adequately controlled with aliskiren or
    hydrochlorothiazide (HCTZ) monotherapy to TEKTURNA HCT. Switch a patient whose
    blood pressure is not adequately controlled with aliskiren or amlodipine (or
    another dihydropyridine calcium channel blocker [DHP-CCB]) alone to combination
    therapy with TEKAMLO.

    Use AMTURNIDE for patients not adequately controlled with any two of the
    following: aliskiren, DHP-CCB, and thiazide diuretics. Switch a patient who
    experiences dose-limiting adverse reactions attributed to an individual
    component-while on any dual combination of components of AMTURNIDE-to AMTURNIDE
    at a lower dose of that component to achieve similar blood pressure reductions.

    TEKTURNA HCT, TEKAMLO, and AMTURNIDE may be substituted for their titrated

    Safety and efficacy of aliskiren in pediatric patients have not been

    Base the choice of TEKTURNA HCT or TEKAMLO as initial therapy on an assessment
    of potential benefits and risks. Individualize the decision to use a combination
    as initial therapy by weighing factors such as baseline blood pressure, the
    target goal, and the incremental likelihood of achieving goal with a combination
    compared to monotherapy.


    When pregnancy is detected, discontinue TEKTURNA, TEKTURNA HCT, TEKAMLO, or
    AMTURNIDE as soon as possible. Drugs that act directly on the renin-angiotensin-
    aldosterone system can cause injury and even death to the developing fetus. See
    Warnings and Precautions (5.1).

    Contraindications: Do not use aliskiren with angiotensin receptor blockers
    (ARBs) or ACE inhibitors (ACEIs) in patients with diabetes because of increased
    risk of renal impairment, hyperkalemia, and hypotension.
    Because of the HCTZ component, TEKTURNA HCT and AMTURNIDE are contraindicated in
    patients with anuria or hypersensitivity to sulfonamide-derived drugs like HCTZ.
    Hypersensitivity reactions may range from urticaria to anaphylaxis.

    Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or
    larynx has been reported in patients treated with aliskiren and has necessitated
    hospitalization and intubation. This may occur at any time during treatment and
    has occurred in patients with and without a history of angioedema with ACEIs or
    angiotensin receptor antagonists. Discontinue TEKTURNA, TEKTURNA HCT, TEKAMLO,
    or AMTURNIDE immediately in patients who develop angioedema, and do not
    Hypotension: In patients with an activated renin-angiotensin-aldosterone system
    (RAAS), such as volume- and/or salt-depleted patients receiving high doses of
    diuretics, symptomatic hypotension may occur in patients receiving RAAS
    blockers. Correct these conditions before administering TEKTURNA, TEKTURNA HCT,
    TEKAMLO, or AMTURNIDE, or start the treatment under close medical supervision.

    Risk of MI or Angina: Rarely, initiation or change to the dose of a calcium
    channel blocker has resulted in the increased frequency, duration, or severity
    of angina or acute myocardial infarction, particularly in patients with severe
    obstructive coronary artery disease.

    Impaired Renal Function: Avoid use of TEKTURNA, TEKTURNA HCT, TEKAMLO, or
    AMTURNIDE with ARBs or ACEIs in patients with moderate renal impairment (GFR <60
    mL/min). Monitor renal function periodically in patients receiving aliskiren, as
    changes in renal function, including acute renal failure, can be caused by drugs
    that affect the RAAS. Patients whose renal function may depend in part on the
    activity of the RAAS (eg, patients with renal artery stenosis, severe heart
    failure, post-MI, or volume depletion) or patients receiving ARB, ACEI or NSAID
    therapy may be at particular risk for developing acute renal failure on
    aliskiren. Consider withholding or discontinuing therapy in patients who develop
    a clinically significant decrease in renal function.

    Hepatic Considerations: Amlodipine is extensively metabolized by the liver, and
    the plasma elimination half-life is 56 hours in patients with impaired hepatic
    function. In patients with severe hepatic impairment, start amlodipine at 2.5 mg
    per day, a dose not available in TEKAMLO and AMTURNIDE.

    Hyperkalemia: Monitor serum potassium periodically in patients receiving
    aliskiren. Drugs that affect the RAAS can cause hyperkalemia. Risk factors for
    the development of hyperkalemia include renal insufficiency, diabetes, and
    combination use of aliskiren with ARBs or ACEIs, NSAIDs, potassium supplements,
    or potassium-sparing diuretics.

    Cyclosporine, Itraconazole, or Lithium: Avoid use of TEKTURNA, TEKTURNA HCT,
    TEKAMLO, or AMTURNIDE with cyclosporine or itraconazole. Additionally, avoid use
    of TEKTURNA HCT or AMTURNIDE with lithium.

    Important Considerations Due to the HCTZ Component: Hypersensitivity reactions
    to HCTZ may occur in patients with or without a history of allergy or bronchial
    asthma, but are more likely in those with such a history. Thiazides have been
    reported to cause exacerbation or activation of systemic lupus erythematosus.
    HCTZ can cause hypokalemia and hyponatremia. Hypomagnesemia can result in
    hypokalemia which appears difficult to treat despite potassium repletion. HCTZ
    may alter glucose tolerance and raise serum levels of cholesterol and
    triglycerides. HCTZ may raise serum uric acid level and may cause or exacerbate
    hyperuricemia and precipitate gout in susceptible patients. Monitor calcium
    levels in patients with hypercalcemia receiving TEKTURNA HCT or AMTURNIDE, as
    HCTZ may cause elevations of serum calcium.
    HCTZ, a sulfonamide, can cause an idiosyncratic reaction resulting in transient
    myopia and angle-closure glaucoma. Symptoms include acute onset of decreased
    visual acuity or ocular pain and typically occur within hours to weeks of drug
    initiation. Discontinue HCTZ as rapidly as possible in these patients. Risk
    factors for developing acute angle-closure glaucoma may include a history of
    sulfonamide or penicillin allergy.

    Common AEs: Adverse events (AE) with increased rates for TEKTURNA compared with
    placebo included: diarrhea (2.3% vs 1.2%), cough (1.1% vs 0.6%), rash (1.0% vs
    0.3%), elevated uric acid (0.4% vs 0.1%), gout (0.2% vs 0.1%), and renal stones
    (0.2% vs 0%).

    Adverse events with increased rates for TEKTURNA HCT compared with placebo
    included: dizziness (2.3% vs 1.0%), influenza (2.3% vs 1.6%), diarrhea (1.6% vs
    0.5%), cough (1.3% vs 0.5%), vertigo (1.2% vs 0.5%), asthenia (1.2% vs 0%), and
    arthralgia (1.0% vs 0.5%).

    The AE in a placebo-controlled trial that occurred in at least 2% of patients
    treated with TEKAMLO and at a higher incidence than placebo was peripheral edema
    (6.2% vs 1.0%). The incidence of peripheral edema at high dose was 8.9%.

    The most common AEs in a short-term controlled trial that occurred in at least
    2% of patients treated with AMTURNIDE were peripheral edema (7.1%), dizziness
    (3.6%), headache (3.6%), and nasopharyngitis (2.6%).

    The foregoing release contains forward-looking statements that can be identified
    by terminology such as "to be withdrawn, " "will, " "potential, " or similar
    expressions, or by express or implied discussions regarding potential future
    revenues from Tekturna. You should not place undue reliance on these
    statements.  Such forward-looking statements reflect the current views of
    management regarding future events, and involve known and unknown risks,
    uncertainties and other factors that may cause actual results with Tekturna to
    be materially different from any future results, performance or achievements
    expressed or implied by such statements. There can be no guarantee that Tekturna
    will achieve any particular levels of revenue in the future. In particular,
    management´s expectations regarding Tekturna could be affected by, among other
    things, unexpected clinical trial results, including unexpected new clinical
    data and unexpected additional analysis of existing clinical data; unexpected
    regulatory actions or delays or government regulation generally; competition in
    general; government, industry and general public pricing pressures; unexpected
    manufacturing issues; the company´s ability to obtain or maintain patent or
    other proprietary intellectual property protection; the impact that the
    foregoing factors could have on the values attributed to the Novartis Group´s
    assets and liabilities as recorded in the Group´s consolidated balance sheet,
    and other risks and factors referred to in Novartis AG´s current Form 20-F on
    file with the US Securities and Exchange Commission. Should one or more of these
    risks or uncertainties materialize, or should underlying assumptions prove
    incorrect, actual results may vary materially from those anticipated, believed,
    estimated or expected. Novartis is providing the information in this press
    release as of this date and does not undertake any obligation to update any
    forward-looking statements contained in this press release as a result of new
    information, future events or otherwise.

    About Novartis
    Novartis provides innovative healthcare solutions that address the evolving
    needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
    offers a diversified portfolio to best meet these needs: innovative medicines,
    eye care, cost-saving generic pharmaceuticals, preventive vaccines and
    diagnostic tools, over-the-counter and animal health products. Novartis is the
    only global company with leading positions in these areas. In 2011, the Group´s
    continuing operations achieved net sales of USD 58.6 billion, while
    approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
    amortization charges) was invested in R&D throughout the Group. Novartis Group
    companies employ approximately 124,000 full-time-equivalent associates and
    operate in more than 140 countries around the world. For more information,
    please visit

    Novartis is on Twitter. Sign up to follow @Novartis at

    # # #

    Novartis Media Relations

    Central media line : +41 61 324 2200

    Eric Althoff Christina Clinton
    Novartis Global Media Relations Novartis Pharmaceuticals
    +41 61 324 7999 (direct) +41 61 324 8682 (direct)
    +41 79 593 4202 (mobile)


    For Novartis multimedia content, please visit
    For questions about the site or required registration, please contact:

    Novartis Investor Relations

    Central phone: +41 61 324 7944

    Susanne Schaffert +41 61 324 7944 North America:

    Pierre-Michel Bringer +41 61 324 1065 Helen Boudreau +1 212 830 2404

    Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445

    Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456

    e-mail: e-mail:

    --- End of Message ---

    Novartis International AG
    Postfach Basel

    WKN: 904278;ISIN: CH0012005267;

    Media release (PDF):

    This announcement is distributed by Thomson Reuters on behalf of
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    (i) the releases contained herein are protected by copyright and
    other applicable laws; and
    (ii) they are solely responsible for the content, accuracy and
    originality of the information contained therein.

    Source: Novartis International AG via Thomson Reuters ONE

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    Novartis announces Aliskiren will continue to be available to appropriate patients, as FDA interim assessment is concluded; product information updated

    Novartis International AG /
    Novartis announces Aliskiren will continue to be available to appropriate
    patients, as FDA interim assessment is concluded; product information updated
    . Processed and transmitted by Thomson Reuters ONE.
    The issuer is solely responsible for the content of this announcement.

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