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Teva's New Copaxone Formulation (3X a Week) For MS Patients Approved By FDA

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  • Teva's New Copaxone Formulation (3X a Week) For MS Patients Approved By FDA

    PRESS RELEASE: The U.S. Food and Drug Administration (FDA) has approved Teva’s supplemental new drug application (sNDA) for a new formulation for Copaxone. Copaxone is now available in 40mg/mL in a three-times-a-week dosage.

    The new formulation offers physicians and patients with relapsing forms of multiple sclerosis (MS) the option to dose less frequently. Copaxone (glatiramer acetate injection) is administered subcutaneously. Daily 20mg/mL doses will continue to be available in addition to the new formulation.

    North America Specialty Medicines President Larry Downey said, “For more than 20 years, Teva has pursued its multiple sclerosis research with the goal of providing effective, safe and tolerable therapies for MS patients. We have progressively invested in the innovation of Copaxone in an effort to understand the needs and to ease the burden of patients who live with relapsing forms of MS every day. Today we are proud to continue to deliver on that investment by offering the freedom to dose three-times-a-week with Copaxone 40 mg/mL.”

    The FDA approved the new formulation following positive data from Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study showing that a 40 mg/mL dose of Copaxone administered subcutaneously three-times-a-week significantly decreased rates of MS relapse at 12 months. More than 1,400 patients participated in the study.

    Omar Khan, Professor of Neurology and Chair of the Department of Neurology at the Wayne State University School of Medicine in Detroit, Michigan said, “The availability of three-times-a-week Copaxone 40 mg/mL is a significant advancement for patients as they now have the option of effective and safe treatment with Copaxone …Patients in the U.S. can now benefit from an improved dosing regimen without compromising the known benefits of Copaxone.”

    Copaxone’s daily subcutaneous injection was first approved in 1996. The drug is approved in over 50 countries worldwide including Canada, Australia, Israel, and in the EU. Copaxone’s new formulation is expected to be available in distribution outlets soon.
    Dave Bexfield
    ActiveMSers

  • #2
    Copaxone New Dosage

    I am loving to hear that there is a new dosage! I appreciate that because taking Copaxone bites and it is painful to take but seems to be effective.How are others feeling about this medication?

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    • #3
      Hey NoMSing, I always liked my Copaxone (strange thing to say about a drug you administer with a needle). I had no significant side effects and taking it in the morning with my coffee was easy. I'm not sure which woke me up more--the shot or the caffeine. It's great that they have a new dosage, but the daily shot never bugged me too much. I forgot maybe two times in three years since it was such a routine. But poking yourself fewer times is all good, and it means fewer injection site reactions. Too bad 40mg wasn't available earlier for me!

      BTW, I don't now if you saw that Copaxone is somewhat effective at delaying brain atrophy, more so than the interferons, so that is another plus.
      Dave Bexfield
      ActiveMSers

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      • #4
        I stared Copaxone last February and feel it is working for me. Prior to being dxed in jan 13, I would have an attack of double vision every winter like clockwork, but nothing as of yet.

        I think I'll stay with the daily injections since they really don't bother me and I have the same routine (the same shot location for a given day). Good luck with the new dosage.

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        • #5
          Member Laura has this Q. Can anyone help?

          I'd just like to see if there is any discussion regarding changing to the 3x a week prescription. I changed over to this as after 10 years of daily ejections my body needs a break. Within a few weeks I had a relapse that affects my gait and coordination on my right site. I'm on my 4th day of oral steroid treatment and doing much better. I had to have this done a year and a half ago. Typically the impact of MS on my daily life is minimal. Hoping to keep it that way ;-) Is anyone else experiencing relapses switching to the 3x a week. The Dr says to stick with it, research says it is a good option, etc. Research is one thing but if people are experiencing issues that tells me it is not.
          Dave Bexfield
          ActiveMSers

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