Washington, DC) On November 16, 2010, the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee voted overwhelmingly (13 to 2) to recommend BENLYSTA® for approval as a treatment for the autoimmune disease lupus. Subsequently, FDA officials announced a final decision regarding approval has been delayed until March 10, 2011.
Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) has issued the following statement:
“We are pleased that BENLYSTA has cleared a significant hurdle on its path to becoming the first FDA-approved medication for lupus in 52 years – since Dwight D. Eisenhower was president. BENLYSTA is now on track to become the first approved treatment ever developed specifically for lupus.
“The recommendation by the FDA Advisory Committee is not only a victory for developers Human Genome Sciences and GlaxoSmithKline, but also for the entire lupus research community and industry. We have all worked for decades to overcome many challenges in developing new therapies for this unique and difficult-to-treat disease. For people with lupus, the panel’s recommendation represents a beacon of hope that new and improved treatments can be specifically developed for lupus.
“It is important to understand that a delayed decision from the FDA does not indicate whether they will approve or reject BENLYSTA. We appreciate the efforts of the FDA to ensure that medications for people with lupus are safe, effective, and tolerable.
The voices of people with lupus were heard loudly and clearly during the hearing. Their testimony demonstrated the urgent need to develop new, safe, effective, and tolerable therapies for lupus. Each person with lupus is unique, and if BENLYSTA is approved, it would be a significant and necessary first step towards creating the full arsenal of treatments that lupus requires.
The LFA thanks the committee and FDA officials for their time and review to ensure the safety and efficacy of this potential medication for people with lupus. We also want to thank the numerous individuals with lupus and their families, who provided testimony and attended the hearing to show their support.
We are greatly encouraged by the panel’s vote, and eagerly await the FDA’s final decision. The LFA will continue to follow this process closely, and keep constituents apprised of developments.
About the Lupus Foundation of America
The Lupus Foundation of America (LFA) is the foremost national nonprofit organization dedicated to finding the causes of and cure for lupus, and providing support, services, and hope to all people affected by lupus. The LFA and its national network of chapters, support groups, and local representatives conduct programs of research, education, and advocacy.
About Lupus
Lupus is an unpredictable and potentially fatal autoimmune disease in which the immune system is out of balance, causing inflammation and tissue damage to any organ system in the body. The health effects of lupus include heart attacks, strokes, seizures, and organ failure. An estimated 1.5 million Americans and at least five million people worldwide have a form of lupus. For more information, visit www.lupus.org .
About BENLYSTA
BENLYSTA was developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) as an investigational therapy to treat lupus and last year successfully met its endpoints in two pivotal Phase III clinical trials.
Many people don’t know that lupus affects millions of people everyday no matter what race or age or sex. Lupus affects mostly women when their just starting life after college. It comes on like a ton of bricks; your life is forever changed. It takes away hopes, and dreams, life. Everyone is affected by lupus differently; no patient is alike in symptoms or struggles. One person may have kidney problems and another person may have heart ailments. The problem with lupus is has no rules, it affects the entire body.
You can help by making a donation to the lupus foundation of America. America’s Giving Challenge has challenged organizations to raise the most donations between Octoberto November through Facebook, but you don’t need a Facebook account. The prize for the organization that raises the most money is 50,000 dollars and daily cash donations. 50,000 dollars can change a lot of people’s life if the scientists are given the money to test new treatments for lupus. There hasn’t be a treatment for lupusin over 50 years, right now a clinical trial is going on that’s showing promising results, but research cost money. Please help the Lupus Foundation of America Find a cure for LUPUS because life with lupus sucks.
For the first time in over 50 years there is a drug that’s showing remarkable progress to help lupus patients fight this disease that takes away life everyday and reduces the quality of life of millions. All I can say it’s a great day to thank all the great scientists who worked so hard. You can read more about it over at Lupus Foundation of America’s Website. If I could I’d jump up and down, so instead I’ll type it. I’m sharing the video of the President & CEO of the Lupus Foundation, Sandra C. Raymond. I must say it’s a great day.
The CDC is really concerned about the outbreak of the Swine also called H1N1. Most people are wondering if they should get the shot or not. I’m concerned about taking the shot this year because the clinical trial is done over such a short time, but the Lupus Foundation of America is monitoring the situation. The best way to deal with the flu is by taking preventive measures.
Here are some tips to help you stay well:
1.) Wash your hands frequently with soap and water and use a paper towel to turn of the faucet. It defeats the purpose by touching the faucet that you’ve already dirtied with your hands.
2.) Wash your hands when you first come home.
3.) Carry a bottle of hand sanitizer in your purse or car. When your kids get in the car have them use it before they touch anything. I use to send a bottle of hand sanitizer with my daughter to school in her lunch box and one in her backpack. The one in the lunch box so she can wash before she eats as the school didn’t give them the opportunity to wash hands. They teach kids to wash their hands before eating in preschool then they get in elementary school and they forget it. Never did understand this one.
4.) If your sick stay home.
5.) Don’t touch your eyes, nose or mouth.
6.) If you’re sick wear a mask to prevent further spread of the flu and wear one if your immunity is down. It’s better to be safe then sorry.
The Lupus Foundation of America has some good articles on the upcoming flu season.
I don’t know exactly where to start really. I had the doctors’ appointment from hell. Recently, I lost the doctor that validated my symptoms, in this post. that gave me a diagnosis of peripheral neuropathyafter 4 years of horrible pain in my legs that was to the point of me screaming in pain. I went to the new doctor and I will never go back to that doctor’s office. He was a total jerk. He told me that my symptoms are psychology; mind you it can be caused by lupus and 30 % of it has no reason that’s found. Ask me if I had psychiatric disorder. Needless to say I am very pissed.He said that peripheral neuropathy does not vary from day to day, which is not true. Got pretty livid that I could not explain what caused the neuropathy, mind you LUPUS can cause it. On top of that he informed me that my old doctor did not know what he was talking about, but EMG’sdon’t lie. He informed me that neuropathy does not come and go which is crap. You know and they wonder why people stay away from doctors. Then started on me about the lupus. Mind you I have 5 Doctors that confirmed my diagnoses. I have the old “it’s in your head crap before, but this Doctor beats them all. Then tries to give me a medication that you can not mixed with my other medication, but mind you he said the nerve pain is my head, talk about double talking. I take lyrica and you can not take Neurotin with it because they call Lyricathe super neurotin. I was told this by both my old neurologist and my rheumatologist whom made it very clear. You know it’s a crying day in heck when some quack-in-the-box, as my daughter calls him, which knows you for 5 minutes tell you that your freaking symptoms are psychological. I have not lived with lupus for over 7 years with blood tests to prove for some jerk to say this garbage. I am very upset. Some doctors just have no compassion. Why would I bring on my pain…? Then he informs me he wants to run another EMG because he does not agree with the operator, which was my old neurologist. Makes me wonder if there is a reason behind it as I know my neurologist left because of the politics at the office, which I heard with my own two ears. I got very upset about him wanting me to endure this test again; the EMG was the most painful test in my LIFE, I was almost in tears when he wanted me to have this test AGAIN. This was the worse test I ever endured and for him to say he wants to prove my symptoms are psychological is ridiculous, mind you LUPUS CAN CAUSE IT. Mind you I come home and my blood results are abnormal. So I guess he would say blood work is psychological too. I think NOT
Sorry for yelling, but This angers me so much, and I don’t get angry easy !!!!
It was interesting finding out which famous people have lupus or have died from lupus. Many of us “unknowns” feel very alone living with lupus. Maybe someone won’t feel so alone living with lupus by seeing some celebrities living with or a victim of Lupus. This is not meant to make anyone sad. It just my way of sharing LUPUS AWARENESS…
Tim Raines, a former baseball player
Ferdiand Marcos, former philipine dictator- died from lupus in 1989
Michael Jackson- has Discoid Lupus since early 1980’s
Caroline Dorough-Cochran, sister of Back Street Boys, died at age 32
Mercedes Yvette, runner up to from Season 2 of America’s Next Top Model
Millie, President Bush’s Dog ( I did not know dogs could have lupus.)
Elaine Page, British Actress and Singer
Seal, singer -discoid lupus to face
Ray Walston- character Actor
Louisa May Alcott, an American author
Do you know anyone who has lupus famous or not ? Please Share…
Updated List:
American writer Flannery O’Connor
Charles Kuralt
Seal
Anna Nicole Smith
Elaine Paige
Lady Gaga, an entertainer/singer
I’m adding the people from the comment listings, if you know some more please tell me.
Yesterday, I went to my 4 month check to the rheumatologist. It’s always a long ride there and back. We left in the morning and didn’t get home until 5 pm. It made for a really long day. I’ve had this upper respiratory stuff and he had to give me an antibiotic. He checked me for pneumonia and it came back clear. That was a major relief. I still have other tests out, but this is a major relief.
I have to go a rheumatologist so far away because I’ve dealt with a lot of my symptoms are in my head. Many doctors don’t want to diagnosis you with lupus. I totally understand that, but refusing to treat symptoms is unrealistic. I suffered in pain with little relief for 4 years because of ignoring my symptoms. I can say I’m thankful for the doctors I have today. All of them listen to me and react when they need to. I feel more like a patient, then a number in their checkbook.
Good doctors and nurses are hard to find. If you have good doctors hang on to them because they are hard to find.
The lupus had me totally wore out. I am so lacking in energy, wheeling across the floor makes me feel like crap. I hate what this illness has done to my body. I want to do so many things. Well lupus has a mind of its own. Just using the computer wears me out. It zaps what energy I do have out of me. I have tried to eat just about anything to boost my energy level. I’ve tried chocolate, caffeine, protein and carbs. It does not help at all. I will be glad when this flare passes. I am grateful to be able to type this tonight, but man this is so tiresome. I feel more like I’ve walked a marathon then wheeled across the room just to type this up. I pray God will release the devil in me and many others called lupus. It sure does suck. I feel like every breath has been taken away from me. I don’t know why this illness does this to me. I want a few good days. I am really hating winter and the transition to spring. God give me strength.
Wick Davis over at the Lupus Foundation of America’s Blog was so nice to create a Walk for Lupus Logo for us bloggers. I can email anyone the link to send it to and the graphic so you can have your walk for lupus graphic for you site. Just leave me a comment and I’ll send you them both. You can see the graphic in the sidebar.
The Lupus Foundation of America has many walks for lupus coming up. I can’t walk myself because there’s no walk near me and I can’t handle the long time out in the sun. I am sensitive to the sun. Lupus makes some people photosensitive. The person’s body does not react normally to the affects of the sun. If I’m out in the sun for too long it usually sends me in to a full flare. It’s not as bad if I cover myself up from the sun.
I really need the sun because I have problems with not getting enough vitamin D levels. About a year ago my vitamin D levels were critical. I had my doctor’s nurse yelling at me because she couldn’t reach me. My phone voicemail wasn’t working right. I couldn’t understand why she was so upset over a supplement. I checked the internet for information on vitamin D supplements. Last time, I had my D levels check was not normal again. Once again I was put on 50,000 units of Drisdol once a week for 8 weeks. I take high dose calcium and vitamin D supplements by doctors orders. I go back to the doctor next month. He told me that people with lupus and other autoimmune disorders have difficulty with keeping vitamin D in there body. He actually told me somewhere they are doing a study about it.
Vitamin D is received into the body from the sun and from your diet. Now I can see why in school they preached about drinking enough milk and getting out in the sun. Well outdoor sun isn’t an option for me too long. When I do go outside I usually wear my silly aqua colored hat with the floppy sides to cover my face. It’s the kind of hat that blossom use to wear on the TV show. I have tried finding a different hat and most of them don’t cover my face enough. I have special sun block that I wear when I’m out in the sun. And let me tell you that stuff is greasy.
The lupus foundation of America has a few articles on vitamin D deficiency. The article I read states the vitamin D deficiency is the most common deficiency in lupus patients. There is also a good web module on lupus and bone health.
