Amevive gets cmte. okay
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryBiogen's Amevive (alefacept) is safe and effective for use in moderate to severe chronic plaque psoriasis, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee agrees in an eight to two vote (with one abstention) at its May 23 meeting. Based on concerns about serious infections (0.91% of Amevive patients vs. 0.24% of placebo patients) and malignancies (1.1% vs. 0.5%), the committee supports Biogen's proposal to develop a registry to track serious adverse events. Amevive use should not be limited to patients who have failed or had an inadequate response to phototherapy or systemic therapy, the committee say
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