FDA delays ruling on Acorda's MS drug until Jan.
Acorda Therapeutics says FDA extends Fampridine-SR review by 3 months until Jan. 22
On 6:38 am EDT, Thursday October 22, 2009 Companies: Acorda Therapeutics, Inc.
HAWTHORNE, N.Y. (AP) -- Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months.
The agency was due to make a decision by Thursday, but the ruling is now due by Jan. 22, 2010.
Acorda said the FDA extended its review because it recently submitted new information on its risk evaluation strategy for the drug.
Acorda sent in the additional information following a meeting with an FDA panel on Oct. 14. The panel recommended that Fampridine-SR receive FDA approval.
Source:
http://finance.yahoo.com/news/FDA-delays-ruling-on-Acordas-apf-3235846838.html?x=0&.v=1
About Fampridine-SR
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics and manufactured by Elan Corporation plc.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
Source:
http://finance.yahoo.com/news/Acorda-Therapeutics-Reports-bw-2362944900.html?x=0&.v=1
About MS
Multiple sclerosis is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord. More than 400,000 Americans have MS, most between the ages of 20 and 50, with women affected two to three times more than men. Worldwide, MS may affect 2.5 million individuals.
Research indicates 64%-85% of people with MS have difficulty walking, and 70% report walking to be the most challenging aspect of their MS. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and, in later stages, up to a third of patients are unable to walk.
