NEW FDA APPROVED DRUG FOR RR MS
New drug approved by FDA for Relapsing Remitting MS!!!!
Her is information on this exciting new drug!
WASHINGTON—The Food and Drug Administration on Wednesday approved a Sanofi SA SAN.FR -0.55% pill to treat multiple sclerosis, making it the second oral therapy that will be available on the U.S. market.
The drug, teriflunomide, will be sold with the brand name Aubagio to treat people with the relapsing remitting form of MS.
Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision; it affects about 400,000 Americans and 2.5 million people world-wide.
The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Most MS patients are of the "relapsing-remitting" type, where the disease flares up periodically and largely disappears for long periods.
Aubagio will compete with Novartis AG's NOVN.VX +0.45% oral pill Gilenya, which was approved by the FDA in 2010 and has been available in Europe since 2011.
FDA said a clinical trial showed the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo, or sugar pill.
The product was approved with FDA's strictest boxed warning discussing risk of liver problems, which can lead to death, and birth defects. The agency said women of childbearing age need to have a negative pregnancy test before starting Aubagio drug and use birth control during treatment.
The FDA also said doctors should use blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment.
I personally am always afraid of taking new drugs. I feel even though the FDA as approved something is not enough for me. I like to wait a year or so. Shoot I didn't allow my son to get the chicken pox vaccine for 4 years after it came out.*
I think it may be easy for me to say I would wait to use this new drug. I am doing fantastic on Copaxone. I guess I would think differently if I was not. I hate the thought of someone taking a new drug because they are desperate for a "cure". I have seen so many drugs that were approved by the FDA then pulled off the market. Like Redux and Finfin the diet "miracle" drug. Shorty after people were dying and suffering major cardiac problems. There have been a few Rheumatoid Arthritis that have been removed as well. My aunt died from one of these drugs. She took it after the serious side effects had come out. She decided to * Continue taking because the medicine did help her. It's sad that we are willing to risk our lives to take medicine that provides us some relief and a glimmer of hope. I guess at times like that we have to decide quality of life over length of life.*
It's a tough choice for everyone. I just want everyone to be fully informed before they make a choice to take any medication. This applies to newly approved drugs and older ones. We are all very different human beings and need to remember this when reading possible side effects.*
Have a blessed wonderful day!!
Her is information on this exciting new drug!
WASHINGTON—The Food and Drug Administration on Wednesday approved a Sanofi SA SAN.FR -0.55% pill to treat multiple sclerosis, making it the second oral therapy that will be available on the U.S. market.
The drug, teriflunomide, will be sold with the brand name Aubagio to treat people with the relapsing remitting form of MS.
Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision; it affects about 400,000 Americans and 2.5 million people world-wide.
The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Most MS patients are of the "relapsing-remitting" type, where the disease flares up periodically and largely disappears for long periods.
Aubagio will compete with Novartis AG's NOVN.VX +0.45% oral pill Gilenya, which was approved by the FDA in 2010 and has been available in Europe since 2011.
FDA said a clinical trial showed the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo, or sugar pill.
The product was approved with FDA's strictest boxed warning discussing risk of liver problems, which can lead to death, and birth defects. The agency said women of childbearing age need to have a negative pregnancy test before starting Aubagio drug and use birth control during treatment.
The FDA also said doctors should use blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment.
I personally am always afraid of taking new drugs. I feel even though the FDA as approved something is not enough for me. I like to wait a year or so. Shoot I didn't allow my son to get the chicken pox vaccine for 4 years after it came out.*
I think it may be easy for me to say I would wait to use this new drug. I am doing fantastic on Copaxone. I guess I would think differently if I was not. I hate the thought of someone taking a new drug because they are desperate for a "cure". I have seen so many drugs that were approved by the FDA then pulled off the market. Like Redux and Finfin the diet "miracle" drug. Shorty after people were dying and suffering major cardiac problems. There have been a few Rheumatoid Arthritis that have been removed as well. My aunt died from one of these drugs. She took it after the serious side effects had come out. She decided to * Continue taking because the medicine did help her. It's sad that we are willing to risk our lives to take medicine that provides us some relief and a glimmer of hope. I guess at times like that we have to decide quality of life over length of life.*
It's a tough choice for everyone. I just want everyone to be fully informed before they make a choice to take any medication. This applies to newly approved drugs and older ones. We are all very different human beings and need to remember this when reading possible side effects.*
Have a blessed wonderful day!!