Benlysta: Is It What We've Been Waiting For?
In November 2010, a FDA advisory panel questioned the effectiveness of the experimental lupus drug being developed by Human Genome Science. While the FDA panel recommended approval of Benlysta, they raised enough concerns about safety that U.S. sales may be limited. The FDA initially put Benlysta on a 6 month priority review. The FDA usually takes at least 10 months to review drug applications but it grants priority review to drugs that could provide major advances in treatment. With no new lupus drugs in over 50 years (last lupus drug approved was in 1958), any lupus drug should be given priority review. Approval was expected to occur in early December 2010 but instead the FDA decided to extend the review period by 3 months. The FDA should make a decision around March 10th.
Supporters of Benlysta, which would be Human Genome’s first marketed product, believe it works well enough to outweigh the risk of suicide, infection and cancer, the panel said. 2 of the 15 members of the panel voted against recommending approval. The drug’s recommended approval came while public criticism increased due to Benlysta's modest benefit and lackluster results in U.S. clinical trials. Its restrictions and thin efficacy (therapeutic effectiveness) is drawing mixed feedback from rheumatologists.
Benlysta, an intravenous drug also known as belimumab, inhibits the production of antibodies that attack healthy cells in lupus patients. FDA approval of Benlysta may “usher in a new era of enlightenment” in lupus research, Sandra Raymond, president of the LFA (Lupus Foundation of America) testified prior to the Advisory Panels' vote. Raymond was one of more than 30 speakers who spoke in favor of approval of Benlysta before the panel voted. Benlysta’s risks of suicide, infection and cancer were greater in patients taking Benlysta than those patients taking a placebo in clinical trials. The panel reported that the drug was effective but lacked robustness (strength).
Benlysta is still likely to gain approval because it met its primary goal of reducing patients’ symptoms in a 52 week trial. The FDA’s knowledge of the urgent need for more lupus therapies may outweigh their concerns that the drug may not be safe or effective enough. Benlysta, if approved, would be the first medication developed specifically for lupus. Prednisone and some antimalarial drugs were already approved for different conditions when the FDA approved them for use in lupus patients more than 50 years ago.
The chemotherapy drug cyclophosphamide, methotrexate and Cellcept, used in organ transplant patients, are among medications prescribed for lupus patients without FDA approval. While FDA rules allow doctors to prescribe drugs for unapproved purposes, companies can’t market the treatments for those off-label uses. Also, some insurance companies will not cover the drugs or have extremely high copays since they are not specifically approved for use in lupus patients. The long-term use of existing lupus treatments can have debilitating side effects that can be worse than the disease itself, Sandra Raymond said, citing stroke, heart attacks, bone loss, hypertension, infertility and infections are possible side effects. Benlysta will not work for everyone. Candidates will include patients who have failed previous treatments or require high doses of prednisone to control their symptoms and want to reduce their dosage to prevent side effects.
My opinion? Benlysta is not going to be the miracle drug that the lupus community is in desperate need of. Most analysts believe Benlysta will be approved but that it will only be prescribed to a small percent of patients. I know when I was in my last really bad flare, I had to be on prednisone for about 6 months. I already had osteoporosis and steroids weaken your bones but there was no other option. I ended up fracturing both of my feet and my doctor warned me that if I fell, I would probably break my hip since my bone density got worse from the steroids. Fortunately I was able to wean off prednisone after 6 months. If the side effects were not so significant, I would have wanted to stay on steroids forever. When I was on high doses of prednisone, I felt like my old self for the first time since I was diagnosed with lupus over 5 years ago. But it is a double edged sword because of all the side effects. But at this point, there is no other option for many lupies. Sometimes the only thing to save us are steroids so it has to be prescribed despite the risk of debilitating side effects. So for lupies who need to be on steroids long term, any drug that could potentially wean them off them would be welcome. My concern is that its effectiveness will be short lived. The results of the clinical trials at 76 weeks (18 months on benlysta) showed that its effectiveness diminished after one year. So it might be prescribed as a short term therapy only. If lupies can even take a year off steroids, I am sure most would welcome it. So my answer to the question is Benlysta what we have been desperately waiting for? No, it is not the wonder drug that we have all been waiting for but it will help some of us. The successful approval of a lupus drug should motivate other pharmaceutical companies to spend more money on lupus research and development of new treatments. So I am hoping for approval of Benlysta and for the development of even better drugs in the short term that will help more of the lupus population.
For more information on Benlysta, please see my post Details On
Benlysta published on 2/16/2010
xoxo
L.C.
Posted by lupuscelebrity at 2/10/2011 9:46 AM 
Categories: FDA approval, HGSI, lupus drug development, benlysta, human genome sciences inc
Tags: lupus sle FDA Benlysta Human Genome Science LFA Lupus Foundation of America Sandra Raymond steroids FDA Benlysta SLE human Genome Sciences Inc HGSI Sandra Raymond Lupus Foundation of America
Categories: FDA approval, HGSI, lupus drug development, benlysta, human genome sciences inc
Tags: lupus sle FDA Benlysta Human Genome Science LFA Lupus Foundation of America Sandra Raymond steroids FDA Benlysta SLE human Genome Sciences Inc HGSI Sandra Raymond Lupus Foundation of America
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