Monday, June 16, 2008
Amgen Statement on Briefing Materials Prepared for June 18, 2008 DODAC Meeting
Briefing documents for the June 18 Dermatologic and Ophthalmic Drugs Advisory (DODAC) meeting regarding the supplemental biologics license application (sBLA) for Enbrel® (etanercept) for the treatment of moderate to severe plaque psoriasis in the pediatric population are now available at www.fda.gov.
Amgen believes that ENBREL would provide an important clinical option if approved for this small, under-served population of children with moderate to severe plaque psoriasis, and looks forward to discussing with the DODAC and FDA the benefits and risks of ENBREL treatment for these patients who have few approved therapies to help manage their disease.
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