Multiple Sclerosis (MS) Support Group
This community is a place where members can discuss current events and weigh in on what's going on in the world.
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
I would have to have an eye exam first , blood work and at the time of the first dose have to be monitored for 6 hrs.
3-4 months later another eye exam and more blood work. She said is would be avalible Oct 4th. Cost would depend on how much insurance would cover.
I decided against it for now. I have been on every shot but Avonex & I've only been on Betaseron for 3 months. So why stop it if I don't even know if it working yet?!
Plus who knows how much my insurance would cover..
I have done some kind of shot for 3 yrs now so a little while longer won't bother me! I am not too keen on the side affects either. I know every med has side affects but I have had enough crap for right now!
But hey it might be great for someone else or even me in the future..just not right now