Friday, September 10, 2010

We Were Beaten to the Punch! Russia Approves Fingolimod!

Russian Authorities Become First to Sanction Novartis’ Oral MS Therapy

 GEN news highlights: Sep 10, 2010

Russian regulatory authorities have approved Novartis’ Gilenya® 0.5 mg once-daily oral treatment (FTY720; fingolimod) for relapsing remitting multiple sclerosis (MS). Russia is the first country to approve the sphingosine 1-phosphate receptor (S1PR) modulator, and Novartis plans to launch the drug in early 2011.

An FDA decision on Gilenya is expected during September, and the outlook for U.S. approval looks promising, given that the agency’s advisory committee gave the drug a unanimous thumbs up back in June. Gilenya is also under review by the European Medicines Agency and by other regulatory bodies worldwide.
Novartis says Gilenya is the first oral therapy for treating relapsing MS. The Phase III trial program confirmed the drug reduces relapses, disability progression over two years, and brain lesions. Data also showed Gilenya to be more effective than Biogen Idec’s Avonex®, the firm adds. The FDA granted Gilenya priority review status in February 2010, reducing the standard ten-month review to six months. In May, the FDA extended the priority review period by three months to September 2010.

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Aside from the fact that I believe they spelled Gilenia incorrectly, this news gives me chills. This wasn't a dead end, waste of time study (not that I thought so, but I remember my hesitancy when presented with the Clinical Trial option for trying out therapy). It's really coming to pass.

They beat us by 11 days. But it's coming. I expect ticker tape parades, special treatment, and paparazzi everywhere due to the fame we are all going to have once this thing takes the MS world by storm.

Reality check: ticker tape parade is when the paper shredder goes haywire, special treatment comes when you get phone calls from bill collectors asking for you BY NAME! and the paparazzi is just someone in your family catching you having a bad hair day and deciding for some reason that it should be recorded for posterity.

I can be famous if I try hard enough... see?



1 comment:

  1. Hey, just thought I'd let you know that Gilenia is now they have got it wrong, they just had to change the name slightly due to another product with a similar name somewhere in the world!


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