Friday, 21 January 2011

Thumbs down for fampridine

European Medicine's agency gives a negative opinion for fampridine:

"The Committee adopted a negative opinion recommending that fampridine, from Biogen-Idec Ltd, should not be granted a marketing authorisation. Fampyra was intended to be used to improve the walking ability of adult patients with multiple sclerosis."

Where to next?

Click here for EMA notification

4 comments:

  1. I suspect this drug was not supported as it was only partly effective in a minority of patients. Universal improvements in walking for MS patients will only come from effective treatments which encourage repair of the damage to the spinal cord. This treament was only papering over the cracks.

    Where next? Fast tracking agents that may provide neuro-protective properties or promote (of axons and myelin). There are enough patients with SPMS or PPMS who would gladly volunteer as guinea pigs and take the risk of a new agent. We are too bound by the Phase I - III trial approach. Take more risks, be bold, use existing patients who currently have no treatment options. The current trial approach takes too long and is ineffective - Phase I Tysabri didn't highlight the 85 cases of PML etc. The researchers need to get into the mindset of what if it was them who had been diagnosed with this grim disease - it's being treated as academice study, but it's about the suffering of human beings.

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  2. I couldn't agree with you more; I look after people with MS and see them suffering on a daily basis. Their suffering is my main motivation for doing research. However, the regulatory authorities, particularly the EMA, are very conservative and see it as their job to protect patients from unnecessary and undefined risks.

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  3. Yes that is rather dispiriting from the point of view of someone who was hoping to try fampridine :-(

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  4. In the meantime you can always try LDN. It's not a miracle cure, but it is harmless and has done a lot of good. It is not approved for MS, but you can easily obtain it, because it's a generic medicine.

    www.ldntrust.org

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