FTY-720 filed with FDA and EMEA for review and approval
 

"Novartis said on Wednesday it had filed FTY720, also known as fingolimod, for approval in the United States and European Union at the lower dose of 0.5 milligrams, which data showed had the best benefit-risk profile."

I know many good responses and stories about about RRMS. Trials were being done at Johns Hopkins with PP (My type - anyone know anything?)

Publication of trial results in the NEJM this week. Just to let everyone know about adverse events since only top line efficacy data are typically provided -

"Adverse effects were similar in all three trials of cladribine and fingolimod, and rates of events leading to discontinuation of a study drug were low but still at least twice as frequent with high-dose cladribine (7.9% for the 5.25-mg dose) and fingolimod (10% and 14% for the 1.25-mg dose). Herpetic infections occurred among patients receiving both cladribine and fingolimod. The rate of herpes infections among patients receiving the 1.25-mg dose of fingolimod was 5.5%; such infections were serious in three of these patients, two of whom died. Twenty cases of cutaneous herpes zoster were recorded among patients receiving cladribine, three of which were serious. Three solid tissue cancers (pancreatic, ovarian, and melanoma) occurred among patients receiving low-dose cladribine (3.5 mg per kilogram). Basal-cell carcinoma, melanoma, and breast cancer were all more common among patients receiving fingolimod than among those receiving interferon beta-1a. Macular edema was confirmed in 13 patients, 11 of whom received high-dose fingolimod (7 in the FREEDOMS trial and 4 in the TRANSFORMS trial). Of these 13 patients, 11 recovered within 1 to 6 months after discontinuation of therapy, and the condition of the other 2 patients stabilized. Transient bradycardia and first- and second-degree heart block occurred more frequently among patients receiving high-dose fingolimod than in the comparator groups. Lymphocytopenia was frequent in patients receiving both agents, more so with higher doses. Clinicians and patients will need to evaluate the risks and benefits of each of these drugs. Given the recent studies documenting the development of progressive multifocal leukoencephalopathy among patients receiving natalizumab, a monoclonal antibody against 4-integrin,8 close postmarketing surveillance will be important to detect any increase in these or other unexpected adverse effects. "

Paleeeeze....they want us to take this junk and actually pay for it. :eek::eek::eek:

Thanks for the warning, Kom.

My MS center said that Fingolomoid is actually now before the FDA for approval, and it looks like this pill will pass the fire test. It has shown great promise in trials, and many have benefitted from it. Reduced lesion load, improved disability scales, and so forth.

if you start reading the label, you will make yourself crazy. they MUST list every possible, potential, and ever reported side effect anyone has ever had while being anywhere near the stuff. Heck, even the cream I use for psoraisis warns about skin cancer from continued use. scary stuff! If you were given H20 by the MD, he would have to tell you every possible cosequence of using it, including OVER hydration or increased urination from it. really intense reading if you want nightmares.

I hate this stupid disease.

I am worried about pancreatic cancer, though...my neuro is very excited about fingolimod...I'm not so sure...:confused:

I just don't get it.......if approved, docs will happily dole out this chemical nightmare, but with some, ask about LDN with no dangerous side effects, and it's WHOA -- STAND BACK!!!!!! HUH??

Yeah, I hate this stupid disease too!!!!!

I did ask about LDN, and many MDs say the same thing. Many believe it to be in the snake oil catagory. Actually that is exactly what my MD called it. The local guy said its a product of great mystery and he feels that its a placebo effect on most. Anything that can cure Cancer (which raises the bodys immune system) and MS (which lowers the immune system) cant truly exist in the same potion. Said he believes it to be in the same catagory as the bee stings, and other such treatments. :eek:

They want meds that have been through thier double blind studies, and have been measured for years by the FDA, and other such agencies. Look at years ago, they used to say that Vit C or Vit D was a waste of our money. Dont take it, it just makes expensive pee. Now they are telling folks all the time, to increase their C and add in D. Same for multi's. They used to be a children, or pregnant woman thing, now they ask all adult, healthy or sick to take one.

One of these days our MDs will catch up and pay attention. Till then, they stand on their corners saying "prove it in double blinds" sad, just sad.

Am I suppose to be totally confused???? Different Docs spout different things. I had a very proactive doc, he moved away. New one very cautious, double blind guy. New specialist says this, this and that not true. Other docs say this, this and that very true, be aware. All reputable doctors!!! I am my best advocate, choosing what I believe and do. With MS you get a lot of interaction with doctors, a lot of experience, a lot of confusion. Those who were once like gods (doctors) are just humans you find out. No blind trust anymore.

I was kinda friend with a GP, our kids were same age. I was a much better mom. AND she was no fun.