FDA approval for oral MS drug Gilenya(TM)

[MSUK]

Novartis announced that the US Food and Drug Administration (FDA) approved the oral multiple sclerosis (MS) treatment Gilenya(TM) (fingolimod) 0.5 mg daily, a first-line treatment for relapsing forms of multiple sclerosis - the most common forms of the disease.
The FDA approval makes Gilenya the first oral treatment indicated for relapsing forms of MS available in the US.

"Today is a significant and encouraging day for people with relapsing forms of MS in the US," said Nicholas LaRocca, Vice President of Healthcare Delivery and Policy Research at the National Multiple Sclerosis Society. "A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease." ... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309

[gkalman]

An ok story with links to even complete stories in the end:
http://www.fiercepharma.com/story/novar ... 2010-09-22

Those links being:
- get the release from Novartis
http://www.fiercepharma.com/press_relea ... al-gilenya
- find the Biogen statement
http://www.fiercepharma.com/press_relea ... gilenya-tm
- see the WSJ piece
http://online.wsj.com/article/SB1000142 ... lenews_wsj
- check out the Bloomberg story
http://noir.bloomberg.com/apps/news?pid ... eE6UBOEIsQ
- read the article in the Boston Globe
http://www.boston.com/business/ticker/2 ... c_iss.html

[Grumpster]

This is great news although the safety profile has me a little concerned. I have been watching this drug and hoping for the approval, but I think i will wait a bit and see how some of the post market data looks. i expect that many people will opt for this instead of injections, or infusions so there should be a lot of data gathered in a realatively short time. I think I'll keep injecting myself with that Copaxone crap for now, at least for a little while.

This is good news though!!

[Mirry]

Grumpster, how are you finding the copaxone. My specialist wants me to start it and I am being bombarded with calls from the company about getting me on it. I am just not ready to go that route yet, I feel I have other tests and avenues to explore yet.

[msmything]

MIRRY, HOW DID THE CO. GET YOUR NAME, THAT WOULD MAKE ME SOOOOO ANGRY! IT'S YOUR DECISION, AND EVERY DRUG THAT'S OUT THERE HAS GOOD THINGS ABOUT IT THAT PROPONENTS WILL SHOVE AT YOU, THEY'LL SKIP THE OTHER STUFF SOMEHOW...i USED COPAX FOR A YEAR, RELAPSED LIKE CRAZY, AND HAVE LUMPS, BUMPS AND BRUISES STILL...

[Grumpster]

The copaxone is a bummer because it is daily, but it doen not make me feel as lousy as the interferons did like rebif and betaseron. My only real problem is if I inject into an area with little fat like my upper leg or back of arm I sometimes hit muscle and than is a major NO NO with copaxone. The pain is pretty bad when that happens. I believe that the drugs do help slow down the MS monster and so I have been on something since my dx. Some people do well with out the drug but I hsave had enough problems that I do not want a mega relapse from which I have permanent disability, so I take the stuff reluctantly. Not that it will totally prevent that from happening, but if it does at least I will not blame myself for not being on the meds.

I hope you figure out what is best for you. There is no one size fits all treatment for us MSrs.

[HarryZ]

Read the other day that the drug costs $ 4,000/month...ouch!!

Harry

[msmything]

yes it is about 4 grand, I only paid 40 a month..

and yes, there is guilt that i have about not taking advantage of tx, and perhaps looking back and thinking I could have prevented some disability, but though the drug side effects were nothing like those I had on the interferons, it's still poison, and it just was not proving effective. Even when you look at the company data, it looks poor.

I don't know, when ya feel like crap all the time, what's the cause??