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FDA apprives Pegasys/Copegus PRE-FI:LLED SYRINGES

Discussion in 'HEP C HIV' started by gk, Jan 27, 2004.

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  1. gk

    gk Well-Known Member

    January 8, 2004

    FDA Approves Pegasys® (Peginterferon alfa-2a) Pre-filled Syringes
    for the Treatment of Hepatitis C

    --Roche continues effort to enhance hepatitis C treatment options--

    NUTLEY, N.J. (January 8, 2004) - Roche announced today that the
    U.S. Food and Drug Administration (FDA) has approved pre-filled
    syringes of Pegasys® (Peginterferon alfa-2a) for the treatment of
    chronic hepatitis C.
    Pegasys, a pegylated alpha interferon, and Copegus® (ribavirin,
    USP) were approved by the FDA in December 2002 for use in
    combination for the treatment of adults with chronic hepatitis C
    who have compensated liver disease and have not previously been
    treated with interferon alpha. Patients in whom efficacy was
    demonstrated included patients with compensated liver disease and
    histological evidence of cirrhosis.
    Pegasys is the most prescribed interferon therapy in the United
    States for the treatment of chronic hepatitis C.* Roche expects
    Pegasys pre-filled syringes to be available in pharmacies by the
    end of the month. Pre-filled syringes will be packaged four per
    box. Pegasys is currently available in vials as a pre-mixed
    solution.

    “Taking a medication by self-injection can be challenging for some
    people," said Dr. David Bernstein, Director of Hepatology, North
    Shore University Hospital. "Reducing the number of steps
    involved can make the process less intimidating for patients and
    reduce the risk of errors.”

    The introduction of pre-filled syringes is yet another way in
    which Roche is working to add value to the management of hepatitis
    C, including:
    developing approaches to reduce the duration of treatment with
    Pegasys and Copegus and the dose of Copegus therapy for certain
    patients
    introducing Copegus with a list price or wholesale acquisition
    cost that is 43 percent less per milligram than the other available
    brand of ribavirin
    backing Pegasys with the most extensive development program ever
    undertaken in hepatitis C
    formulating Pegasys as a pre-mixed solution requiring no
    reconstitution prior to self-injection

    Hepatitis C is a blood-borne infectious disease of the liver and
    the leading cause of cirrhosis and liver cancer and the number one
    reason for liver transplants in the U.S. An estimated 2.7 million
    Americans are chronically infected with hepatitis C.
    Pegasys is dosed at 180mcg as a subcutaneous injection taken once a
    week. Copegus is available as a 200mg tablet, and is administered
    orally two times a day as a split dose.

    For more information on the Roche pharmaceuticals business in the
    United States, visit the company's web site at:
    http://www.rocheusa.com

    Facts About Pegasys (Peginterferon alfa-2a) in Combination with
    Copegus

    Indication
    Pegasys®, a pegylated alpha interferon, alone or in combination
    with Copegus® (ribavirin, USP) is indicated for the treatment of
    adults with chronic hepatitis C who have compensated liver disease
    and have not previously been treated with interferon alpha.
    Patients in whom efficacy was demonstrated included patients with
    compensated liver disease and histological evidence of cirrhosis
    (Child-Pugh class A).

    Dosing and Administration

    Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous
    injection once a week. Copegus, available as a 200mg tablet, is
    administered at 800 to 1200mg taken twice daily as a split dose.
    The two products are sold separately.

    Combination Therapy Clinical Studies

    The two combination therapy pivotal study findings:

    Study 5, including 1,284 patients receiving medication, showed that
    patients with certain genotypes (strains) of the hepatitis C virus
    should be treated with different dosing regimens of Pegasys and
    Copegus. The treatment regimens and resulting sustained
    virological response rates for these groups treated with Pegasys
    and Copegus therapy were:
    Genotype 1: 48 week duration
     
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