Multiple Sclerosis (MS) Support Group
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From: FDA Office of Public Affairs
To: ORA DDs
Sent: Wed Sep 22 08:20:19 2010
Subject: FDA Approves First Oral Drug to Reduce MS Relapses
5FDA Approves First Oral Drug to Reduce MS Relapses
SILVER SPRING, Md., Sept. 22 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO )
(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )
"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Gilenya is the first in a new class of drugs that block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS.
MS is a chronic, often disabling, disease that affects the central nervous systemthe brain, spinal cord, and optic nerves. According to the National Multiple Sclerosis Society, there are about 400,000 people in the United States and 2.1 million people worldwide with MS.
The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision.
Patients using Gilenya should be monitored for a decrease in heart rate upon starting the drug. Gilenya may also increase the risk of infections. Cases of serious eye problems (macular edema) have occurred in patients taking the drug and an ophthalmologic evaluation is recommended.
The most frequent adverse reactions reported by patients taking Gilenya in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough.
The drug will be available in 0.5 milligram capsules. Gilenya is made by Novartis, Basel, Switzerland.
For more information:
National Institute of Neurological Disorders and Stroke: Multiple Sclerosis Information
http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm
Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
CONTACT: Media Inquiries: Sandy Walsh, +1-301-796-4669; sandy.walsh@fda.hhs.gov, Consumer Inquiries: 1-888-INFO-FDA
To: ORA DDs
Sent: Wed Sep 22 08:20:19 2010
Subject: FDA Approves First Oral Drug to Reduce MS Relapses
5FDA Approves First Oral Drug to Reduce MS Relapses
SILVER SPRING, Md., Sept. 22 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO )
(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )
"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Gilenya is the first in a new class of drugs that block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS.
MS is a chronic, often disabling, disease that affects the central nervous systemthe brain, spinal cord, and optic nerves. According to the National Multiple Sclerosis Society, there are about 400,000 people in the United States and 2.1 million people worldwide with MS.
The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision.
Patients using Gilenya should be monitored for a decrease in heart rate upon starting the drug. Gilenya may also increase the risk of infections. Cases of serious eye problems (macular edema) have occurred in patients taking the drug and an ophthalmologic evaluation is recommended.
The most frequent adverse reactions reported by patients taking Gilenya in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough.
The drug will be available in 0.5 milligram capsules. Gilenya is made by Novartis, Basel, Switzerland.
For more information:
National Institute of Neurological Disorders and Stroke: Multiple Sclerosis Information
http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm
Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
CONTACT: Media Inquiries: Sandy Walsh, +1-301-796-4669; sandy.walsh@fda.hhs.gov, Consumer Inquiries: 1-888-INFO-FDA
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Usually I get a daily influx of emails on health topics. An article from Dr. Mercola really stood out recently though because it mentioned that fat cells have their own mitochondria. Not only was this the first I'd heard of this, he also mentioned that fat serves a purpose in our metabolism. Another new factoid for me. The bottom line for me was to appreciate that even our fat cells play a...
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I just do not feel well and I really think that it's because I cried yesterday on my way to work about my Aunt who is in the hospital. I don't think that we will have her much longer. She is very frail. Now she needs help eating. So, this is the third time in a year that I felt this way after crying. I think crying releases toxins into my body. I also worked up a sweat at the gym...
Is it available widely now? or will it be soon? Im not up on that yet.
I called my doc today and left him a message. I knew it had been approved, but I had read varying reports as to when it would be available.
I just started Copaxone, I can do that, Im happy with the fact that its not making me sick and I can fit it into my life, but a pill would for sure be much nicer than a needle...lol!
I'm searching the web looking at all the side effects and other fun stuff.Lots to consider.
I had read somewhere ( maybe this was old news) that you had to have failed two therapies first before getting and rx for Gilenya. I don't know if that is still the case.
I distinctly remember reading the FDA in its preliminary review advised that it be allowed as a 1st line MS treatment like the crab drugs, not like Tysabri which is a 2nd line drug and a person had to have failed on one of the other druigs first----so with gilinea you wont have to try another MS med first....now cost is another matter..I have no idea what the cost will be.
http://www.msassociation.org/news_center/article.asp?a=gilenya
This new drug sounds very scary to me. I don't think I would be one of the first to jump on the bandwagon with it! Yes, it is an oral medication, but at what cost to the patient? To me it's almost like this new breakthrough doesn't exist it has so many problems with it.
I am glad to know that you don't need two failed therapies as I have never cared to go on any of the injections/infusions.
I along with many others I am sure are in the "wait and see" mode on this one.
In any event, I am glad to know that the first oral medication has been approved at long last! :)
While this is a tremendous advance - an oral pill for M.S. - it does not come without consequences. Do your research before starting it. The MS community does not need a drug problem like Avandia.
Had I been on any of these drugs, I wouldn't be here today. I would have died in November when I developed peritonitis. Of course no doctor cares to admit this but without an immune system you cannot fight off serious infections.
I think extreme caution is a very good call!