Enbrel: The subtext matters

An FDA advisory committee’s narrow vote to approve Enbrel etanercept to treat moderate-to-severe pediatric plaque psoriasis last week would have been much wider had the proposed indication been for severe disease only. The committee also recommended a stringent post-marketing plan for sponsor Amgen Inc.

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 8-5 to recommend approval of the sBLA for Enbrel. If the agency listens to the bulk of the panel members’ comments, however, the drug will receive approval for severe disease only and Amgen will need to step up its post-marketing plans...