ADELPHI, Md., Oct 14 (Reuters) - Acorda Therapeutics Inc's proposed multiple sclerosis drug is safe and effective for improving patients' ability to walk, a U.S. medical advisory panel said on Wednesday.
The U.S. Food and Drug Administration's panel of outside experts said the drug, known by its chemical name fampridine, appeared to help patients, but should not be used in people with known seizure problems. Lower doses also need to be tested, they said.
There is no cure for multiple sclerosis, a chronic disease affecting about 400,000 Americans. It attacks the central nervous system and can result in numbness or paralysis of arms and legs.
Acorda is seeking U.S. approval to sell its drug to treat walking problems that are a main symptom of the degenerative disease. It has proposed the brand name Ampriva, but earlier suggested the name Amaya.
The FDA will weigh the panel's advice before later making its approval decision, which the company expects by Oct. 22.
Trading in Acorda shares was halted earlier on Nasdaq because of the meeting.
(Reporting by Susan Heavey; editing by Andre Grenon) Keywords: ACORDA/ (sheavey@thomsonreuters.com; + 1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The U.S. Food and Drug Administration's panel of outside experts said the drug, known by its chemical name fampridine, appeared to help patients, but should not be used in people with known seizure problems. Lower doses also need to be tested, they said.
There is no cure for multiple sclerosis, a chronic disease affecting about 400,000 Americans. It attacks the central nervous system and can result in numbness or paralysis of arms and legs.
Acorda is seeking U.S. approval to sell its drug to treat walking problems that are a main symptom of the degenerative disease. It has proposed the brand name Ampriva, but earlier suggested the name Amaya.
The FDA will weigh the panel's advice before later making its approval decision, which the company expects by Oct. 22.
Trading in Acorda shares was halted earlier on Nasdaq because of the meeting.
(Reporting by Susan Heavey; editing by Andre Grenon) Keywords: ACORDA/ (sheavey@thomsonreuters.com; + 1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.