Amgen announced that 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 paediatric patients with chronic 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 paediatric patients with an important new treatment option where there is a clear unmet medical need."
The sBLA, submitted on January 5, 2016, is 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 Enbrelin paediatric patients with moderate to severe plaque psoriasis.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 5, 2016, for the Enbrel sBLA application.
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location. Approximately 125 million people worldwide have psoriasis and 80 per cent of those patients have plaque psoriasis. About one-third of psoriasis cases are paediatric.
Enbrel is a soluble form of a tumour necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 15 years of collective clinical experience. Enbrel was first approved in 1998 for moderate-to-severe rheumatoid arthritis. Enbrel 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. Prescription Enbrelis given by injection.
Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.
Enbrel is indicated for reducing signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients ages two and older.
Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. Enbrelcan be used with or without methotrexate.
Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Enbrel is indicated for the treatment of adult patients (18 years or older) with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.