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An FDA advisory panel has concluded that the safety profile of the Johnson & Johnson(J&J)-sponsored rheumatoid arthritis candidate sirukumab did not support approval by the agency, even though the drug’s efficacy was found sufficient for authorization. The FDA’s Arthritis Advisory Committee yesterday voted 12 to 1 against recommending approval based on the safety data, which showed that of the 35 patient deaths reported in sirukumab clinical trials, all but one (34) occurred in patients treated with sirukumab. A total 2,926 patients were treated with either 50 mg or 100 mg doses of sirukumab in five Phase III trials. Thirty-one of the 35 deaths occurred within 16 weeks of last dose of study agent, the FDA disclosed in the staff-prepared Briefing Document on sirukumab submitted to the Committee. The main causes of death, according to the Document, were cardiovascular events (13 patients), serious infections (8), malignancies (6), ...NEXT ARTICLE
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