Oral MS drug, FTY720, works, but has side effects - FDA

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Oral MS drug, FTY720, works, but has side effects - FDA

Postby MSUK » Tue Jun 08, 2010 10:27 pm

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Federal health regulators said Tuesday a highly anticipated Novartis drug for multiple sclerosis appears effective but carries a number of side effects, including lung and eye problems.

Swiss drugmaker Novartis has asked the Food and Drug Administration to approve its drug Gilenia to treat patients with relapsed multiple sclerosis, which causes tremors and movement problems. The drug is a daily pill and would offer an alternative to older injectable drugs.

FDA reviewers said two studies of the drug “provide substantial evidence for an effect.”... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309
MS-UK - http://www.ms-uk.org/
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Postby Needled » Thu Jun 10, 2010 1:00 pm

From the attached article -- The FDA's panel of nervous system experts voted 25-0 today (June 10) that Gilenia (Fingolimod) helps reduce relapses. The panel is scheduled to vote on the drug's safety later this afternoon. The FDA is not required to follow the group's advice, though it usually does.
http://finance.yahoo.com/news/FDA-panel ... 4.html?x=0
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Postby Needled » Thu Jun 10, 2010 4:57 pm

Here's the link to Novartis' press release issued this evening on today's FDA events.

http://hugin.info/134323/R/1423236/372134.pdf
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