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.

10 comments:

Che koala said...

very exciting news

many thanks cause really without your blog I would, I suspect, have been jadedly thinking with the news today that it was 'just another drug from the pharmas' that couldn't make much difference. Your lively blog has influenced my opinion of its possibilities.

cheers muchly

shouldhavezagged said...

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!

Kim said...

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!!

Thomas said...

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!!!

TickledPink said...

Thomas, I sure hope your wife can get on the pill and she experiences the kind of results that I've been blessed with.

For what it's worth, I had been on Copaxone right up until starting this trial and it wasn't working for me at all.

Thanks everyone for your comments! And for reading this drivel. LOL

Thomas said...

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!

TickledPink said...

Awww! Thanks, Thomas! That's the kind of comment that keeps me blogging. :D

Before getting into the trial I had been on (and off) Copaxone for 8 years. Sometimes I couldn't get it because I have no insurance and didn't always qualify for Medicaid and am not on disability.

For 2 solid years before the trial my MS had really kicked into high gear and I was relapsing every 3 months with a full 3 months to recover.

I remember thinking it was like drowning in the ocean. Big MS waves knocking me down and just about the time I'd get my feet back down and stand up again, another wave would be there to knock me back down.

It was horrible and I was at my wit's end. My last MS attack in April of 07 gave me terrible panic attacks (I twice drove myself to the ER sure I was having a heart attack), gave me awful burning in both legs and cramped them up so bad I could hardly walk.

I started the trial (and found out later I was on the real Fingolimod the entire time) and have not yet had another relapse.

While it's true there are some *possible* serious side effects, if anyone is in the boat I was in, where you feel near suicidal due to just not being able to take it any more, I strongly recommend giving it a shot.

I did it because I felt I had nothing to lose and everything to gain.

Best of luck to you and your wife.

Thanks for reading and I will try to be more faithful about popping in with something witty and uplifting to say more often. :D

Jeri

Martin said...

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

TomZoo said...

Quick Update:

My wife saw her neuro again and just a few more tests and we're on our way to Gilenya!! Woop Woop!!!

-Thomas

TickledPink said...

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