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What Could Happen To HGSI’s SLE Drug On Tuesday?

  Monday, November 15, 2010

A few days before the independent FDA committee review of Human Genome Sciences’ (HGSI) systemic lupus erythematosus (SLE) drug Benlysta (belimumab), the FDA suggested that the drug has marginal efficacy and scary adverse effects. The agency expressed concerns about infection, neuropsychiatric complications, including the risk of suicide, and increased risk of death as a result of the use of the drug. The FDA message to the independent committee, which will convene on Tuesday, is to decide whether the reward is worth the high risk. The FDA has also observed that studies conducted outside the U.S. produced stronger data than the U.S.; these studies were not consistent with the U.S. results. The agency has also observed that the African-American lupus patients had benefited less from Benlysta than did non-African American patients.  More...


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