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# FDA Accepts sBLA for Amgen’s Enbrel
- URL: https://www.fdaweb.com/fda-accepts-sbla-for-amgens-enbrel/
- Published: 2016-03-11T12:00:00.000Z
- Updated: 2026-09-15T02:43:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135055

> FDA has accepted for review an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients with chronic severe plaque psoriasis. The submission is supported by data from a Phase 3 one-year study and a five-year open-label extension study. The agency has set a user fee review target date of 11/5\. Enbrel was approved by FDA in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, for treating patients with ankylosing spondylitis in 2003, and in 2004 to treat moderate-to-severe plaque psoriasis in adults.