FDA Approves Expanded Use of Amgen’s Enbrel®

U.S. FDA News

Amgen recently announced that the FDA has approved its supplemental Biologics License Application for the expanded use of Enbrel® (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.  According to Amgen, Enbrel® is now “the first and only systemic therapy” for this indication, the approval of which was “based on results from a Phase 3 one-year study and its five-year open-label extension study to evaluate the safety and efficacy of ENBREL” for this patient population. This approval adds to the array of already approved anti-inflammatory indications for Enbrel®, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis.

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