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Acroda says European committee recommends conditional marketing approval of Fampyra?

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    Acroda says European committee recommends conditional marketing approval of Fampyra?

    Acroda says European committee recommends conditional marketing approval of Fampyra?
    Hawthorne, New York, Monday, May 23, 2011, 10:00 Hrs [IST]


    The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended conditional marketing authorization of Fampyra (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale of 4-7). This oral therapy was developed and is commercialized by Acorda Therapeutics, Inc. in the United States under the trade name Ampyra (dalfampridine) Extended Release tablets, 10 mg. Fampyra is being developed and marketed by Biogen Idec outside the United States under a licensing agreement from Acorda.

    Based on the CHMP recommendation, Biogen Idec expects that a conditional marketing authorization for Fampyra should be granted within 67 days.

    “Ampyra is the first and only medication indicated to improve walking in people with MS, and has been shown to be effective in all major types of MS. Many thousands of people with MS have experienced improvement in their walking ability after initiating treatment with Ampyra, and we are pleased that the CHMP decision should soon allow patients in Europe to have access to this medication,” said Ron Cohen, MD, president and CEO, Acorda. “We will continue working with our partner, Biogen Idec, to make this therapy available in Europe and other markets worldwide” he added.

    In May 2011, Fampyra was approved for use in Australia by the Australian Therapeutic Goods Administration (ATGA).

    As part of the license agreement between Acorda and Biogen Idec, European Medicines Agency (EMA) approval in Europe triggers a $25 million milestone payment to Acorda from Biogen Idec. Acorda may receive additional payments of up to $375 million based on the successful achievement of future regulatory and sales milestones. Under Acorda's existing agreements with Elan Pharma International Limited, a subsidiary of Elan Corporation plc, Acorda will pay Elan seven percent of the milestone payments that Acorda receives from Biogen Idec.




    read...

    http://www.pharmabiz.com/PrintArticl...id=63011&sid=2

    #2
    Excellent news. It means that Europeans with MS will have access to Ampyra soon. Australia recently approved. Wise.

    Originally posted by manouli View Post
    Acroda says European committee recommends conditional marketing approval of Fampyra?
    Hawthorne, New York, Monday, May 23, 2011, 10:00 Hrs [IST]


    The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended conditional marketing authorization of Fampyra (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale of 4-7). This oral therapy was developed and is commercialized by Acorda Therapeutics, Inc. in the United States under the trade name Ampyra (dalfampridine) Extended Release tablets, 10 mg. Fampyra is being developed and marketed by Biogen Idec outside the United States under a licensing agreement from Acorda.

    Based on the CHMP recommendation, Biogen Idec expects that a conditional marketing authorization for Fampyra should be granted within 67 days.

    “Ampyra is the first and only medication indicated to improve walking in people with MS, and has been shown to be effective in all major types of MS. Many thousands of people with MS have experienced improvement in their walking ability after initiating treatment with Ampyra, and we are pleased that the CHMP decision should soon allow patients in Europe to have access to this medication,” said Ron Cohen, MD, president and CEO, Acorda. “We will continue working with our partner, Biogen Idec, to make this therapy available in Europe and other markets worldwide” he added.

    In May 2011, Fampyra was approved for use in Australia by the Australian Therapeutic Goods Administration (ATGA).

    As part of the license agreement between Acorda and Biogen Idec, European Medicines Agency (EMA) approval in Europe triggers a $25 million milestone payment to Acorda from Biogen Idec. Acorda may receive additional payments of up to $375 million based on the successful achievement of future regulatory and sales milestones. Under Acorda's existing agreements with Elan Pharma International Limited, a subsidiary of Elan Corporation plc, Acorda will pay Elan seven percent of the milestone payments that Acorda receives from Biogen Idec.




    read...

    http://www.pharmabiz.com/PrintArticl...id=63011&sid=2

    Comment


      #3
      Still stuck in Canada. I was hoping they were watching what was going to happen in Europe so maybe this will move things along.

      If all goes to my plan with this stupid hysto, I want to have collagen in the bladder sphincter and be trying ampyra and hoping it works somewhat (I had Transverse Myelitis so demyelinated axons). I'm cautiously hopeful this will all work out in the Fall.
      Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

      T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

      Comment


        #4
        Whatever happened to HP184 in Australia and where is Dr Kerr these days?
        Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

        T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

        Comment


          #5
          Lynnifer, Dr Douglas Kerr is with Biogen. Dr Levy has moved into his place at Johns Hopkins in Baltimore. Dr Levy is working on some therapies including Ampyra . whyen I spoke with him, he asked if I knew of Amprya. I told him I already had tried it for about 3 months. I also said I noticed no improvements. I have met one ms patient and spoken with another. They both saw significant imrpovement. Both were able to stand when not able before taking the medication. One stood for about 1 minute and the other said about 1.5 minutes. The ms patient I met was able to lift her legs including knees while sitting in the wheelchair. I recommend that nothing to lose to try it. There is a warning on the drug concerning kidney or liver, can't remember which,

          keeping on

          Comment


            #6
            Thanks keeping on, I had no idea Dr Kerr was with Biogen.
            Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

            T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

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