Summary

Fampridine has been recommended for approval on 10/14. There are several more steps needed at the regulatory level, but the medicine is back on the approval track after a critical pre-meeting FDA report raised serious criticisms.

Analysis

Fampridine is a new class of MS medications, designed to improve a functional outcome. It represents a new treatment option for those with progressive forms of MS. No doubt, the effect is modest, and not experienced by everyone. However, many patients will want to try it, and some patients may find a very significant improvement in their own lives.

Details about how this will be prescribed by the Neurologist, how many patients would be interested in trying, and how many patients would remain on the drug long-term are beginning to become apparent. This is based upon the effficacy results, the safety profile, the FDA expert review, the long-term experience in extension trials, and Acorda's potential capacity to market the medication in the US with Biogen IDEC helping outside the US.

Analyses are solely the work of the authors and have not been edited or endorsed by GLG.