Agency requests new study to evaluate long-term benefits and safety of sustained-release fampridine.
The European Commission yesterday 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 who have walking disability. 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. Biogen Idec says the agency’s requirements are consistent with its already planned postapproval activities.
The firm is developing Fampyra outside the U.S. under license from Acorda Therapeutics. The latter achieved FDA approval of prolonged release fampridine (trademarked Ampyra™) in January 2010 for the MS walking indication. Fampyra was granted approval in Australia two months ago.
The European approval process has not been smooth, however. In January the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against approval. At the time the committee said it wasn’t convinced that the drug’s small effect on walking speed was a meaningful benefit for patients, and in addition noted a lack of adequate long-term data on the medicine’s benefits and safety as well as data on some groups of patients, such as the elderly.
Biogen already markets two MS therapies. Avonex® (interferon beta-1a) generated sales of $2.5 billion worldwide in 2010, an increase of 8% over 2009 sales figures. Tysabri® (natalizumab) achieved net sales of $1.2 billion in 2010, up 16% on 2009.