UPDATE 2-US approves Acorda MS drug to help with walking

Fri Jan 22, 2010 5:56pm EST

 * Ampyra first drug cleared to boost walking speeds in MS
 * Company says drug should be available in March
 * Acorda shares jump nearly 10 pct
 (Adds company, analyst, FDA comments; updates shares)
 By Lisa Richwine
 WASHINGTON, Jan 22 (Reuters) - Acorda Therapeutics Inc
(ACOR.O) won U.S. approval on Friday for the first drug to
improve walking ability in patients with multiple sclerosis.
 MS patients in clinical trials who took the oral drug,
Ampyra, had faster walking speeds than others who got a
placebo, the Food and Drug Administration said in a statement.
 Acorda shares jumped 9.8 percent to close at $28.12 on the
Nasdaq. Shares of Elan Corp ELN.N, which will manufacture the
drug, rose 2.3 percent to $8.04 on the New York Stock
Exchange.
 Acorda Chief Executive Ron Cohen said he expected the drug
will be available in March. He said the company has not yet
disclosed a price, and he declined to give sales projections.
 Mike King, analyst for Merriman Curhan Ford & Co, estimates
Ampyra will have worldwide sales of $1 billion by 2015 or
2016.
 There is no cure for multiple sclerosis, a chronic disease
affecting about 400,000 Americans and 2.5 million people
worldwide. It attacks the central nervous system and can cause
numbness or paralysis of arms and legs. Walking ability tends
to worsen over time and patients may require wheelchairs.
 "Trouble with walking is one of the most debilitating
problems people with MS face," Dr. Russell Katz, head of the
FDA division that reviewed Ampyra, said in a statement.
 Acorda conducted two major studies of the drug, measuring
how fast more than 500 patients given either Ampyra or a
placebo could walk a distance of 25 feet (8 meters).
 In the first study, about 35 percent of patients responded
to the drug versus 8 percent who took a placebo. For the second
study, response rates were 43 percent for the drug and 9
percent for a placebo.
 FDA reviewers had told an advisory panel in October the
difference in walking speed with either group was very small.
But company representatives said the drug's ability to shave a
few seconds off the walking test could add up over the course
of an hour and help with simple tasks such as getting to the
bathroom quickly.
 The panel backed the drug, saying Acorda's data showed it
was safe and effective.
 In Friday's announcement, the FDA said Ampyra can cause
seizures if patients take higher-than-recommended doses, and it
should not be used by patients with moderate to severe kidney
disease. The recommended dose is two 10-milligram tablets per
day.
 FDA spokeswoman Sandy Walsh said the drug did not include a
boxed warning, the strongest type of warning for prescription
drugs. Some industry analysts had expected a boxed warning.
 The drug's generic name is dalfampridine.
 (Reporting by Lisa Richwine and Bill Berkrot, Editing by
Robert MacMillan and Matthew Lewis)


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