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FDA to Approve New Drug for Lupus Patients After Nearly 50 Years

11/22/2010
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It has been almost 50 years since a drug to treat lupus has been approved by the FDA. This week the FDA voted in favor of the new drug Benlysta 13-2 to treat lupus. A final decision to approve the new drug will be made by December 9 and it could be available to consumers by early next year, 2011.

Lupus is a poorly understood disease leading to chronic inflammatory disease that occurs when the body’s immune system attacks its own tissues and organs. More than 90 percent of those afflicted with lupus tend to be women in their 30’s and 40’s. Symptoms can include fatigue, fever, joint pain, stiffness and swelling, rashes, skin lesions, mouth sores, hair loss and chest pain. Symptoms are extreme and severe in many patients. The disease will continue to attack the internal organs and eventually lead to death.

To date only three drugs have been approved for treating lupus including aspirin, the steroid prednisone, and Plaquenil. However all of these drugs can have serious side effects including stomach bleeding, weight gain, bruising, high blood pressure and diabetes, vision problems and muscle weakness. Chemotherapy drugs are also used to treat the disease and can cause hair loss, anemia, and diarrhea. New studies released by drug manufacturer Human Genome Sciences and GlaxoSmithKline show that, “The experimental drug Benlysta significantly reduced lupus symptoms in a randomized trial of more than 850 patients, reducing their need for debilitating steroids and chemo treatments and improving quality of life.”

Opponents of the drug said that Benylsta did not show patients faring any better than those taking older therapies and the therapies did not work on certain races, such as African-Americans. According to the Human Genome Sciences study, “Only 30 percent of patients studied responded to the drug and the drug did not help African-Americans- who are three times more likely to have lupus than Caucasians.”  However, patients who did perform well with Benylsta strongly encouraged the FDA approval of the medication because the drugs side effects are relatively mild compared with that of current treatments which can be debilitating.

Dr. Daniel Wallace of UCLA’s Geffen School of Medicine, is hopeful about the new drug for lupus. He has treated patients over the past four years with Benylsta and has seen them get better and better. “The fact that they could taper off steroids in the drug group really speaks well for the drug,” says Wallace. “This is going to be a major breakthrough, no question about it.”

Margaret G. Dowd, president of the Lupus Research Institute, is also excited about the new breakthrough for lupus patients. “We have had many disappointments, so for a drug to make it through the door with a very significant success rate is an extraordinary accomplishment,” said Dowd. “Not only does the trial offer lupus patients the hope of a new treatment with fewer side effects, but it should also offer encouragement to other companies with lupus drugs in the pipeline.”

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