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FDA Staff Report Says Glaxo, Human Genome Lupus Medicine May Not Be Safe

November 15, 2010
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U.S. regulators weighing approval of the first new treatment for the autoimmune disorder lupus said GlaxoSmithKline and Human Genome Sciences Inc.’s experimental lupus drug Benlysta may not be safe, reports Bloomberg. Human Genome shares plunged 11 percent. Benlysta’s risks of suicide, infection and cancer were greater than those in patients taking a placebo in clinical trials, Food and Drug Administration staff said today in a preliminary review on the agency’s website. Data showing the drug was effective lacked “robustness,” the agency staff said. Outside advisers to the FDA will meet Nov. 16 to assess the medicine’s effectiveness and safety, and recommend whether it should be approved for sale. Benlysta would be the first treatment approved by the FDA since 1958 for lupus, a chronic condition that causes the immune system to attack healthy cells and affects about 5 million people worldwide. While high doses of Benlysta met primary goals of two trials, there was a “lack of demonstrated efficacy” in black patients in the U.S. and an “inconsistent efficacy trend across different geographical regions of the world,” the agency staff said.

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