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news.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.
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The sBLA is based on results from a phase 3 one-year study and its five-year open-label extension trial to assess the safety and efficacy of Enbrel in pediatric patients with moderate to severe plaque psoriasis.
The Prescription Drug User Fee Act target action date for the sBLA is 5 November 2016.
Amgen executive vice president of research and development Sean Harper said: "If approved, Enbrel would be the first systemic drug approved in the U.S. to treat chronic severe plaque psoriasis in pediatric patients.
"We hope to be able to provide pediatric patients with an important new treatment option where there is a clear unmet medical need."
Enbrel is a soluble form of a tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 15 years of collective clinical experience.
It was initially approved in 1998 for moderate-to-severe rheumatoid arthritis. In 1999, Enbrel was approved for the treatment of moderate-to-severe polyarticular juvenile idiopathic arthritis,
Enbrel was approved 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.