FTY720 oral MS treatment gets unanimous FDA approval

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FTY720 oral MS treatment gets unanimous FDA approval

Postby MSUK » Fri Jun 11, 2010 2:50 am


Novartis investigational treatment FTY720 (fingolimod) has received unanimous FDA approval for the treatment of patients with relapsing multiple sclerosis (MS).

The advisory committee of FDA, that reviews and decides whether to approve a new treatment, has voted that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5mg dose justified approval.

Novartis said that the committee has assessed data from the clinical trial program which provided evidence of superior efficacy of FTY720 over interferon beta-1a IM (Avonex), and to placebo, in reducing relapses and brain lesions (a measure of disease activity).... 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 » Fri Jun 11, 2010 12:47 pm

And the estimated cost is ... $30,000 year. Sadly, that's just about what I was expecting. See linked article for more about the drug. Pricing is mentioned in the last paragraph.
http://www.marketwatch.com/story/novart ... teid=yhoof
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Postby hwebb » Fri Jun 11, 2010 4:50 pm

I'm sure they've set the cost so high as they know they've set the dose too high. The post-release studies will likely indicate a lower dose is needed to elicit the desired response....so they'll have to drop the recommended dose (and cost) in a couple of years time. Greedy bastards.
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