The FDA staff questioned whether the proposed Acorda Therapeutics (ACOR) drug to treat multiple-sclerosis increased walking speed was clinically meaningful.
 
Following this news the stocks of Acorda went down 22% and reached $17.35 on more than twelve times its regular trading volume, as the FDA’s questions looked to dent confidence in the drug’s quick approval.
 
An FDA panel of outside medical experts will review the proposed drug fampridine-SR this week and FDA’a review of the drug is available on its website.
 
The panel is required to vote on whether it approves of the safety standard and efficiency at improving the walking patients with MS. The panel will also be questioned whether Acorda should be required to study the drug at a lower dose.
 
Analysts, Robert Baird & Co. analyst Christopher Raymond urged clients to stay on sidelines due to the risk linked to the panel meeting and agency’s concerns of the drug’s effectiveness, even after two positive clinical trials.
 
Geoffery Meacham, an analyst with JPMorgan believes that the agency’s questions are not surprising and the data on the drug will withstand regulatory scrutiny.
 
Acorda is going to hold a risk-management program to educate patients and doctors about the importance of following the 10-milligram dose and not taking two pills at once.
 
Multiple sclerosis is a disease which damages the nerves which control muscles and vision and affects about 400,000 Americans.