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news.Biogen Idec has received negative opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for recommending the approval of Fampyra (prolonged-release fampridine 10mg tablets) to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union.
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Fampyra 10mg tablets are prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine or 4-AP).
Biogen Idec Neurology Research & Development head Alfred Sandrock said tens of thousands of people with MS have already received the therapy in the US, where it is approved, and many have reported important benefits.
"We will work closely with the CHMP during the appeal process to address the Committee’s concerns, with the goal of making this important medication available to MS patients in Europe," Sandrock said.