FDA Accepts sBLA for Amgen’s EnbrelBy
The US Food and Drug Administration (FDA) has accepted for review Amgen’s supplemental biologics license application (sBLA) for the expanded use of Enbrel (etanercept) to treat pediatric patients with chronic severe plaque psoriasis.
The sBLA, submitted on January 5, 2016, has a Prescription Drug User Fee Act target action date of November 5, 2016.
Enbrel is a soluble form of a tumor necrosis factor (TNF) receptor. It was first approved in 1998 for moderate-to-severe rheumatoid arthritis. It was approved in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, for the treatment of patients with ankylosing spondylitis in 2003, and in 2004 to treat moderate-to-severe plaque psoriasis in adults.