Wednesday, September 22, 2010

Today is the day!! The FDA Approves Gilenya (Fingolimod, FTY720)

I had been watching closely all day yesterday for the mention of approval, but went to bed broken hearted.

Today was a mad house of domestic flurries and I forgot all about checking the FDA site. I even forgot to check my email all day until just now.

How fitting it was, then, that the first email I should happen upon was that of my clinical trial coordinator. She sent no message but rather a link to an article announcing the FDA approval.

I'm elated, excited, overjoyed and nearly in tears about this news. Whether tears of joy for all who have been awaiting the pill, or tears of sorrow as a chapter in my life will soon be ending and I will once again have to figure out how to pay for my meds, I'm not sure.

I feel like jumping up and down and I don't know why there's no fireworks when I look outside... surely it will be on the evening news, right?? I mean this IS BIG! The first EVER pill for MS. Wow! And I've been on it for 3 years already!


Anyhow, here is the news straight from Novartis' mouth:
http://www.novartis.com/newsroom/media-releases/en/2010/1445917.shtml

And another link on Bloomberg Business Week:
http://www.businessweek.com/news/2010-09-22/novartis-awarded-u-s-approval-for-ms-pill-gilenya.html

I guess I have to get used to saying "Gilenya" now. Took me forever to learn to spell Fingolimod. Thanks Novartis.

Really, though... THANKS NOVARTIS!! -- and CONGRATULATIONS! You gave me my life back one pill at a time. I wish you much success with lots more MSers out there.

6 comments:

  1. I came across your blog in Google Reader not too long ago. It helped me put a face on the fingolimod trial (so to speak). You were the first person I thought of when I read the news today of the drug's FDA approval.

    I was diagnosed with MS in November 2009 and I'm on my second medicine. I hate the injections. I see my neurologist in a few weeks and I plan to ask about Gilenya...although I have to say that the side effects scare me a bit.

    Take care, congratulations, and good luck!

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  2. Yay!! I think there should be fireworks too! And congrats to all of us who have been on it for these last 3 years +! Without us contributing to the science behind the statistics they are citing, it would not be here for all to start enjoying! Yay!!

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  3. What awesome news! I have been reading this blog for sometime now as my wife was DXed in 2002. She's done Novantrone, Betaseron and Copaxone...and has been steadily declining. We pray that Gilenya will work better than Copaxone, her current treatment. Thanks again for publishing your blog!!!

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  4. Wow...I guess I didn't read that far back in your blog to see you were on Copaxone before it started!! My wife went from using a cane to a wheelchair this past summer (veryyy hot weather) and has the dreaded "dead" left leg from a nasty lesion at her C5/6. I'm not sure how bad a place you were in before the trial started but she could sure use a boost...physically and mentally.

    BTW, hardly "drivel"!! LOL It has become "MUST READ" in our house!

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  5. Hey very exciting news. My girlfriend has been diagnosed with relapsing and remitting ms. Her neurologist has suggested Gilenya. I have never heard of it before , and must admit I am rather worried about the possible side effects. Have you experienced any of these?? Also have you heard about ccsvi? It might interest you. Cheers

    Martin

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  6. I am SO happy for you Thomas! I hope she has the same great results I've been blessed to experience!

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