New Lupus Treatment

FDA approves first new lupus treatment in over five decades.
The CBS Evening News (3/9, story 12, 0:20, Couric) reported that the Food and Drug Administration "today approved a new drug for treating lupus, the first in more than 50 years."
According to the Washington Post (3/10, Overly) reports that Benlysta (belimumab), developed by Human Genome Sciences and GlaxoSmithKline, "reduces the disease's level of activity by inhibiting a bodily protein called the B-lymphocyte stimulator, which at elevated levels can contribute to the creation of autoantibodies." Curtis Rosebraugh, Director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said, "Benlysta, when used with existing therapies, may be an important new treatment approach for healthcare professionals and patients looking to help manage symptoms associated with this disease."
The Los Angeles Times (3/10, Zajac) notes that one of Benlysta's benefits is that "patients can use less prednisone, a steroid used to control symptoms," said Cynthia Aranow, co-director of autoimmune diseases and clinical research at the Feinstein Institute for Medical Research in Manhasset, New York. She said the ability to be "'steroid-sparing is very important' because prednisone has numerous troubling side effects including osteoporosis, diabetes and high blood pressure."
Meanwhile, the AP (3/10, Perrone) points out that "experts stress that Benlysta is not a miracle drug: It only worked in 35 percent of North American patients tested and was not effective for patients with the deadliest form of the disease." Also, it did not "show positive results in African Americans, who are disproportionately affected by lupus. FDA said in its news release it would require the drug developers to conduct another study exclusively in African Americans."
The New York Times (3/10, Pollack) adds that the drug is "not recommended for patients whose disease is severely damaging their kidneys or central nervous systems because it was not tested on those patients." According to the Chicago Sun-Times (3/10, Thomas) reports, the "most common side effects associated with belimumab in a pair of clinical trials were nausea, diarrhea and fever." The Wall Street Journal (3/10, Winslow, Dooren, subscription required), Dow Jones Newswire (3/10, Dooren, Gryta, subscription required), HealthDay (3/9) and MedPage Today (3/9, Gever) also covered the story.