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May 16, 2011

Australia Approves Biogen Idec’s Fampyra for Improving Walking Ability in Multiple Sclerosis

  • Biogen Idec reported Australian regulatory authority approval for Fampyra (fampridine) 10 mg modified-release tablets to help improve walking ability in adult patients with multiple sclerosis (MS) who have shown improvement after eight weeks of treatment. Approval covers use of Fampyra either as monotherapy or as part of combination therapy with other MS drugs. Biogen Idec says studies showed the oral potassium channel blocker was effective in patients with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing, and primary progressive). Biogen Idec is developing Fampyra outside the U.S., under license from Acorda Therapeutics. FDA approval of the drug in the U.S. (where it is trademarked Ampyra™) was achieved by Acorda 2010.

    Approval of Fampyra in Australia was based on data from two Phase III clinical trials, which showed that the treatment boosted improvements in walking speed by 35–43%, compared with the 8–9% increases achieved in the placebo arms of the two studies. The improved response rates in the Fampyra cohorts was observed across all types of MS included in the studies. Fampyra-treated patients who responded to therapy experienced average increases in walking speed of about 25%.

    Fampyra is a modified-release tablet formulation of fampridine (4-aminopyridine, 4-AP, or dalfampridine), developed using Elan’s Matrix Drug Absorption System (MXDAS™) technology. In January 2011 the EMA's Committee for Medicinal Products for Human Use recommended against the approval of Fampyra in the EU for the walking ability indication. Biogen Idec and Acorda are now working together on an appeal against the negative opinion.

    Acorda reported net revenues of $46.8 million from U.S. sales of Ampyra in the three months prior to March 31, 2011. The firm projects achieving net Ampyra sales-related revenues of $205–$230 million over the whole year.

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