FDA to Review Enbrel for Pediatric Plaque Psoriasis
Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for review their supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept), to treat pediatric patients with chronic severe plaque psoriasis.
Enbrel is a tumor necrosis factor (TNF) blocker. It was first approved in 1998 to treat moderate-to-severe rheumatoid arthritis. It was subsequently approved in 1999 to treat polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, in 2003 to treat ankylosing spondylitis, and in 2004 to treat plaque psoriasis in adults.
The new sBLA is based on results from a Phase 3 1-year study and its 5-year open-label extension study to evaluate the safety and efficacy of Enbrel in pediatric patients with moderate to severe plaque psoriasis.
"If approved, Enbrel would be the first systemic drug approved in the U.S. to treat chronic severe plaque psoriasis in pediatric patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We hope to be able to provide pediatric patients with an important new treatment option where there is a clear unmet medical need."
Juvenile Idiopathic Arthritis study showed adverse reactions in pediatric patients were generally similar in frequency and type as those seen in adult patients.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 5, 2016, for the Enbrel sBLA application.
For more information visit Enbrel.com.