This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryResults of a second Phase III Xanelim trial, presented July 30 at the American Academy of Dermatology meeting, show that 22% of patients receiving 1 mg/kg Xanelim and 28% of patients given 2 mg/kg once weekly achieved the study's primary endpoint of a 75% or greater improvement in the Psoriasis Area Severity Index score after 12 weeks treatment vs. 5% of placebo patients. The trial enrolled 597 patients with moderate to severe plaque psoriasis. A second 12-week course of treatment in 134 partial responders resulted in a 75% or greater improvement in PASI score for 58% of patients receiving Xanelim 2 mg/kg weekly and 29% for those receiving 2 mg/kg every other week vs. 4% for placebo. Genentech aims "ultimately to position [efalizumab] for chronic and/or maintenance therapy" of psoriasis, Genentech Product Development Head Bernice Welles, MD, said during a July 31 conference call. Results of the firm's first pivotal trial were presented June 21 (Pharmaceutical Approvals Monthly, July 2001, p. 21)
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