FDA panel to review Acorda drug on Oct. 14
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- August
- 25
October 14th will be an important day for Acorda Therapeutics Inc., a Hawthorne-based biotech company.
That’s when a U.S. Food and Drug Administration panel is scheduled to conduct a critical review of Fampridine-SR, Acorda’s new multiple sclerosis drug that is designed to make walking easier for the disease’s victims. Acorda has been working on the development of the drug since the mid-1990s.
Investor optimism about the drug’s potential has helped fuel a rise of more than 800 percent in Acorda’s stock price since September 2006.Analysts said that a final FDA decision on Fampridine-SR may slip past an earlier deadline of Oct. 22.
“It would seem nearly impossible for the FDA to approve Fampridine so quickly after the panel” conducted its review on Oct. 14, Phil Nadeau, a Cowen & Co. analyst, said in a note to clients, according to Bloomberg News. “Nonetheless, assuming a positive panel, the delay is likely to be modest (three months or so).”
Acorda recently reached agreement with another biotech company, Biogen Idec of Cambridge, Mass., to handle the marketing and regulatory approvals for the Fampridine-SR medication in foreign markets. Acorda already sells Zanaflex, a treatment for involuntary muscle movements caused by multiple sclerosis and spinal injuries.
This entry was posted
on Tuesday, August 25th, 2009 at 1:22 pm by Jay Loomis.
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