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.FDA Panel Backs Proposed Acorda MS Drug To Improve Walking
5:32 pm ET 10/14/2009- Dow Jones
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--A Food and Drug Administration panel Wednesday backed a proposed Acorda Therapeutics Inc. (ACOR) drug to improve walking in patients with multiple sclerosis.
The panel said the drug, fampridine-SR, appeared to be safe and effective at increasing walking speed, although it noted the drug would likely work in about one-third of patients.
Specifically the panel voted 12-to-1 in favor of a question that asked if the company "demonstrated substantial evidence of effectiveness of fampridine as a treatment to improve walking in patients with multiple sclerosis." On a question that asked if "do you conclude that there are conditions under which fampridine could be considered safe," the panel voted 10-to-2 in favor. The votes amount to a recommendation that the FDA approve fampridine-SR. The FDA usually follows the advice of its panels but isn't required to do so.
In a statement, Ron Cohen, Acorda's president, said the panel outcome "was an important regulatory milestone."
Acorda's stock, which last traded at $16.74, was halted Wednesday during the meeting.
Cohen noted that walking impairment is one of the most common side-effect related to MS and said there's currently no FDA-approved treatment that directly addresses walking impairment.
Fampridine has been associated with a seizure risk at higher doses than the 10-milligram dose for which Acorda is seeking FDA approval. The panel said a lower dose of the drug should be studied but said the agency should allow the study to be conducted after the drug is approved and not prior to approval.
The FDA said one study of about 300 patients showed that 34.8% of patients receiving fampridine-SR had an improvement in walking speed compared to 8.3% in the placebo group. Patients were timed as part of a 25-foot walking test at different time points during treatment. Another study involving 237 patients showed 42.9% of patients in the fampridine group had an improvement in walking speed compared with 9.3% of patients in the placebo group.
But an agency reviewer said the "improvement in walking speed is of small magnitude and of uncertain clinical significance." Looking at the studies in combination, the FDA said about one-third of patients appeared to benefit from the drug.
The active ingredient in the drug, fampridine, has been compounded in pharmacies for more than 20 years and used to improve walking in a number of neurological conditions. The drug is currently not approved by the FDA for any use.
The FDA said data from the clinical trial of fampridine-SR at 10-milligrams given twice a day didn't show a difference in the seizure risk compared to patients treated with a placebo, or fake drug. However, the agency said in briefing documents prepared for the meeting that there was a tenfold increase in the risk of a seizure when the drug was dosed at 20-milligrams twice daily, "a concerning finding suggesting a narrow therapeutic index."
Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision, and affects about 400,000 Americans. The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Fampridine-SR is designed to help the body's electric signals to pass through by blocking potassium ions that leak from the damaged nerves. |
