The FDA is expected to decide on approval by early 2015, according to Novartis, which plans to market secukinumab as Cosentyx if approved. The FDA usually follows the recommendations of its advisory panels. Members of these two panels had no conflicts to disclose; occasionally, panelists with a conflict are given a waiver, but not at this meeting. Secukinumab is not yet approved elsewhere, and is also under review in Europe. Phase III studies in patients with psoriatic arthritis are underway.
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FDA Panel Unanimously Supports Secukinumab Approval for Psoriasis
Publish date: October 20, 2014
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Elizabeth Mechcatie, Family Practice News Digital Network
AT AN FDA ADVISORY COMMITTEE MEETING