EC Conditionally Approves Multiple Sclerosis Drug Fampyra
Under terms of the approval conditions, the European regulator is recommending the firm carry out a further study to evaluate long-term benefits and safety of the drug.
The European Commission has granted conditional marketing approval for Biogen Idec’s Fampyra (prolonged release fampridine tablets) as a treatment to improve walking in adult multiple sclerosis (MS) patients.
A conditional approval is renewable yearly, and under terms of the approval conditions for Fampyra, the European regulator is recommending that the firm carry out a further study to evaluate long-term benefits and safety of the drug, in particular its benefits beyond effects on walking speed.
The firm is developing Fampyra outside the U.S. under license from Acorda Therapeutics. The latter achieved FDA approval of prolonged release fampridine (Ampyra) in January 2010 for the MS walking indication. Fampyra was granted approval in Australia two months a
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