美國食物藥品管理局"喜歡"Acorda"的MS藥物: Fampridine

美國食物藥品管理局"喜歡"Acorda"的MS藥物: Fampridine

October 15, 2009, 8:38 AM ET

By Jacob Goldstein

An experimental multiple sclerosis drug many not help most of the patients who take it, an FDA advisory panel said yesterday. But a benefit for a minority of patients was enough to convince the panel to vote in favor of fampridine-SR, Dow Jones Newswires reports.

美國食品藥物管理局諮詢委員會昨日以12比1的

Shares of Acorda Therapeutics, a small company that’s developing the drug, rose more than 40% in after-hours trading. As often happens when a small drugmaker is heavily dependent on a single, experimental drug, Acorda’s shares have been on a roller-coaster, rising and falling with the drug’s prospects.

In clinical trials, more than a third of patients who took the drug showed improvements in walking speed, compared with fewer than 10% of patients who took placebo. But as we noted just last week, FDA documents released ahead of yesterday’s meeting said the improvement in walking speed among some patients who took the drug was “of small magnitude and uncertain clinical significance.” That caused Acorda shares to fall more than 20% .

臨床證實, 比起服用安慰劑的病人, 超過1/3的MS病患服用了 fampridine之後, 能夠增進走路的速度.

Yesterday’s panel voted 12-1 that the drug “demonstrated substantial evidence of effectiveness … as a treatment to improve walking in patients with multiple sclerosis.” And the vote was 10-2 in favor that “there are conditions under which fampridine could be considered safe.” The FDA doesn’t have to follow the recommendations of its panels, but it usually does.

Biogen Idec, which also sells the multiple sclerosis drug Tysabri, has the rights to sell the drug outside the U.S.

又一新藥的出現, 繼續加油吧!!

美國食物藥品管理局"喜歡"Acorda"的MS藥物: Fampridine