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Human Genome falls on Benlysta docs

November 13, 2010 1:03 AM UTC

Shares of Human Genome Sciences Inc. (NASDAQ:HGSI) fell $2.88 (11%) to $23.60 on Friday after FDA described the efficacy of Benlysta belimumab as "somewhat marginal" in briefing documents posted ahead of Tuesday's Arthritis Advisory Committee meeting to discuss the lupus candidate. The agency also expressed safety concerns and noted that Benlysta appears to be associated with an increase in death, serious adverse events, infections, and neuropsychiatric adverse events, including suicide.

While Benlysta met the primary endpoint of patient response rate in two Phase III trials, FDA said one of the studies was "less robust." The agency also said data on other endpoints and from subgroup analyses were not "consistently supportive." The documents noted there were three completed suicides in Benlysta patients and an additional four cases of suicide attempts or suicidal ideation, but no cases in placebo patients. Additionally, FDA said the safety of combining Benlysta with more potent immunosuppressives, including possibly other biologics, has not been adequately evaluated. FDA did add that neuropsychiatric manifestations are a not uncommon complication of lupus. ...