UPDATE 2-Acorda shares fall over FDA concerns for MS drug
* Secondary review indicated "very limited effect"
* FDA advisers to weigh drug on Wednesday
* Shares fall more than 18 percent (Adds share price, company comment, background on drug)
By Susan Heavey
WASHINGTON, Oct 9 (Reuters) - Acorda Therapeutics Inc's
(ACOR.O) proposed drug to help multiple sclerosis patients walk
better appears to have a "very limited effect" even though the
drug met its main clinical trial goals, U.S. regulatory staff
said in documents released on Friday.
Shares of the drugmaker fell more than 18 percent after the Food and Drug Administration released the staff scientists' review.
While Acorda's drug, called Amaya, does not aim to treat the degenerative disease, the company is seeking FDA approval as a treatment to help improve patients' ability to walk. On Wednesday of next week, a group of outside experts will meet to discuss the drug and offer the FDA advice about whether to allow its use.
Multiple sclerosis is a degenerative disease that affects the central nervous system and can cause vision problems, muscle weakness, difficulty balancing and even paralysis in some more serious cases.
"Walking impairment is one of the most common MS-related functional impairments and can lead to profound disability and reduced quality of life," Acorda said in separate documents released on Friday.
The company said its two studies showed that Amaya "provides rapid, significant, and clinically relevant improvements in walking ability" and that patients reported positive experiences with its use.
One study of nearly 300 patients found that 35 percent of the 224 Amaya-treated subjects improved their walking speed compared with 8 percent of the 72 patients given a placebo.
Looking at percentages, there was a statistically significant difference in patients' walking ability, but the actual time it took patients on average to walk 25 feet was not different for those given the drug versus a placebo, the FDA staff said.
Additionally, secondary analyses of the data "gave inconsistent results, and indicated a very limited effect on walking speed," they added.
"For these reasons, it appears that the clinical meaning of the differences seen ... is in question," FDA staff said in their review.
Amaya contains fampridine, which is widely known to cause seizures -- a factor that also must be weighed, the FDA staff said. The risk for seizures is linked to the dose, and the FDA said it also planned to ask its advisers if Acorda should study a dose smaller than the proposed 10 milligram version before being approved.
Despite the FDA staff's concerns, some analysts said they expected the drug ultimately to receive the agency's backing.
J.P. Morgan analyst Geoff Meacham and his colleagues said some of the FDA's concerns came as "a modest negative surprise," but that the agency's advisory panel was likely to support the drug.
Acorda's stock was off 17.6 percent at $18.35 in midday trade on the Nasdaq. (Reporting by Susan Heavey, editing by Dave Zimmerman and Matthew Lewis)
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