Last updated on April 19, 2014 at 12:41 EDT

EDURANT(R) (rilpivirine) Receives Positive Opinion From the Committee for Medicinal Products for Human Use (CHMP) for Use in Treatment-Naive Adults with HIV-1

September 23, 2011

TITUSVILLE, New Jersey, September 23, 2011 /PRNewswire/ –

– Third HIV medication submitted by Tibotec -

Tibotec Pharmaceuticals (Tibotec), one of the Janssen Pharmaceutical
Companies, announced today that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive
opinion recommending the approval of EDURANT(R) (rilpivirine), a 25 mg
tablet, as a once-daily treatment in combination with other antiretroviral
agents (ARVs), for the treatment of human immunodeficiency virus type 1
(HIV-1) infection in antiretroviral treatment-naive adult patients with a
viral load less than or equal to 100,000 HIV-1 RNA copies/mL. EDURANT is a
medicinal product in the non-nucleoside reverse transcriptase inhibitor
(NNRTI) class.

The CHMP positive opinion is a critical step in the approval process and
will be considered by the European Commission, which has authority to
approve medicines for use throughout the European Union. EDURANT was
approved by the U.S. Food and Drug Administration (FDA) in May 2011 (see
below for the U.S. indication and important safety information) and by the
Canadian Health authorities (Health Canada) in July 2011. Applications for
approval have also been submitted in other countries, including Switzerland
and Australia.

The positive opinion is based on 48-week analyses of ECHO and THRIVE,
two phase 3 clinical trials which evaluated the efficacy, safety and
tolerability of EDURANT in treatment-naive HIV-1 adult patients in over 20
countries. The 48-week analyses of both ECHO and THRIVE were published in
the 16th July 2011 edition of the Lancet.[1,2]

“We are committed to developing new and innovative treatment options for
HIV; EDURANT will offer a further option for patients who are starting HIV
combination therapy for the first time,” says Wim Parys, MD, Global Head,
Infectious Diseases, Janssen. “We are encouraged by this positive opinion
from the CHMP and will work closely with regulatory authorities to make
EDURANT available to HIV patients in Europe.”

EDURANT is also combined with Gilead’s TRUVADA(R) (emtricitabine
200mg/tenofovir disoproxil fumarate 300mg) in a once-daily single-tablet
regimen, which was submitted under a separate Marketing Authorisation
Application (MAA) and is currently under assessment by the EMA. The fixed
dose combination of EDURANT and TRUVADA was approved by the U.S. FDA in
August 2011.

Parys added: “We are pleased to partner with Gilead, one of the leading
companies in the fight against HIV/AIDS, which shares our dedication to
improving treatment options for people living with HIV.”

About EDURANT (rilpivirine)

EDURANT is an NNRTI, which blocks reverse transcriptase, a key enzyme
that the HIV virus uses to replicate. The EMA regulatory application for
EDURANT is based on the 48-week results of two pivotal Phase 3 double-blind,
randomized studies known as ECHO (TMC278-C209) and THRIVE (TMC278-C215).[1,2
]The studies evaluated the efficacy, safety and tolerability of once-daily
EDURANT, in combination with two NRTIs, in treatment-naive HIV-1-infected
adults, and both achieved their primary objective of demonstrating
non-inferiority of EDURANT vs. efavirenz in the percentage of patients
achieving an undetectable viral load (less than 50 copies/mL) at week

U.S. Indication

EDURANT is indicated in combination with other antiretroviral agents for
the treatment of human immunodeficiency virus type 1 (HIV-1) infection in
antiretroviral treatment-naive adult patients.

This indication is based on Week 48 safety and efficacy analyses from
two randomized, double-blinded, active controlled, Phase 3 trials in
treatment-naive patients and Week 96 safety and efficacy analyses from a
Phase 2b trial in treatment-naive patients.

The following points should be considered when initiating therapy with

        - More EDURANT treated subjects with HIV-1 RNA greater than
          100,000 copies/mL at the start of therapy experienced virologic failure
          compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the
          start of therapy.
        - The observed virologic failure rate in EDURANT treated subjects
          conferred a higher rate of overall treatment resistance and
          cross-resistance to the NNRTI class compared to efavirenz.
        - More subjects treated with EDURANT developed
          lamivudine/emtricitabine associated resistance compared to efavirenz.

        U.S. Important Safety Information

        - Coadministration of EDURANT(TM) with the following drugs is
        contraindicated because significant decreases in rilpivirine plasma
        concentrations may occur due to CYP3A enzyme induction or gastric pH
        increase, which may result in loss of virologic response and possible
        resistance and cross-resistance: carbamazepine, oxcarbazepine,
        phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, proton pump
        inhibitors such as esomeprazole, lansoprazole, omeprazole, pantoprazole,
        and rabeprazole, systemic dexamethasone, and products containing St.
        John's wort (Hypericum perforatum)

        Warnings and Precautions
        - Depressive Disorders: Severe depressive disorders, defined as depressed
        mood, depression, dysphoria, major depression, mood altered, negative
        thoughts, suicide attempt, and suicidal ideation, have been reported with
        EDURANT(TM). Immediate medical evaluation is recommended for severe
        depressive symptoms
        - Fat Redistribution: Redistribution and/or accumulation of body fat have
        been observed in patients receiving antiretroviral (ARV) therapy. The
        causal relationship, mechanism, and long-term consequences of these events
        have not been established
        - Immune Reconstitution Syndrome has been reported in patients treated
        with combination ARV therapy, including EDURANT(TM)

        Drug Interactions
        - EDURANT(TM) should be used with caution when coadministered with drugs
        that may reduce the exposure of rilpivirine, such as antacids and
        H2-receptor antagonists
        - EDURANT(TM) should be used with caution when coadministered with a drug
        with a known risk of Torsade de Pointes
        - EDURANT(TM) should not be used in combination with NNRTIs
        This is not a complete list of potential drug interactions.
        Please see full Prescribing Information for more details.

        Use in Specific Populations
        - Hepatic Impairment: EDURANT(TM) should be used with caution in patients
        with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of
        EDURANT(TM) have not been evaluated in these patients
        - Pregnancy Category B: EDURANT(TM) should be used during pregnancy only
        if the potential benefit justifies the potential risk. No adequate and
        well-controlled studies have been conducted in pregnant women

        Adverse Reactions
        - The most common adverse drug reactions reported (incidence >2%) of at
        least moderate intensity (=Grade 2) in patients
        taking EDURANT(TM) through 48 weeks were depressive disorders (4%),
        insomnia (3%), headache (3%), and rash (3%)

Please see full Prescribing Information for more details, available at:


You are encouraged to report negative side effects of prescription drugs
to FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About Tibotec

Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies of
Johnson & Johnson, is a global pharmaceutical and research development
company. The Company’s main research and development facilities are in
Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is
dedicated to the discovery and development of innovative HIV/AIDS and
hepatitis C drugs, and anti-infectives for diseases of high unmet medical

About Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated
to addressing and solving the most important unmet medical needs of our
time, including oncology, immunology, neuroscience, infectious disease, and
cardiovascular and metabolic diseases.

Driven by our commitment to patients, Janssen develops innovative
products, services and healthcare solutions to help people throughout the

More information can be found at http://www.janssen-emea.com.

This press release contains “forward-looking statements” as defined in
the Private Securities Litigation Reform Act of 1995. 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
Tibotec Pharmaceuticals, any of the other Janssen Pharmaceutical Companies
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 and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; domestic and
foreign health care reforms and governmental laws and regulations; trends
toward health care cost containment; and increased scrutiny of the
healthcare 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
January 2, 2011. Copies of this Form 10-K, as well as subsequent filings,
are available online at http://www.sec.gov, http://www.jnj.com or on
request from Johnson & Johnson. The Janssen Pharmaceutical Companies and
Johnson & Johnson do not undertake to update any forward-looking statements
as a result of new information or future events or developments.


        1) Molina J-M et al. Rilpivirine versus efavirenz with
          tenofovir and emtricitabine in treatment-naive adults infected with
          HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial.
          Lancet. 2011; 378: 238-246.
        2) Cohen C et al. Rilpivirine versus efavirenz with two background
          nucleoside or nucleotide reverse transcriptase inhibitors in
          treatment-naive adults infected with HIV-1 (THRIVE): a phase 3,
          randomised, non-inferiority trial. Lancet. 2011; 378: 229-237.


        Karen Manson


        Stan Panasewicz

        Louise Mehrotra

SOURCE Tibotec Pharmaceuticals

Source: PR Newswire