FDA Accepts Application for Expanded Use of Etanercept (Enbrel) to Treat Pediatric Patients With Plaque Psoriasis

Target action date is November 2016

The FDA has accepted for review a supplemental biologics license application (sBLA) for the expanded use of etanercept (Enbrel, Amgen) to treat pediatric patients with chronic severe plaque psoriasis. If approved, etanercept would be the first systemic drug with this indication in the U.S.

The sBLA, submitted in January 2016, is based on results from a one-year phase III study and its five-year open-label extension study to evaluate the safety and efficacy of etanercept in pediatric patients with moderate-to-severe plaque psoriasis. The FDA has set a Prescription Drug User Fee Act target action date of November 5, 2016.

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, although it can appear on any location. Approximately 125 million people worldwide have psoriasis, and 80% of those patients have plaque psoriasis. About one-third of psoriasis cases are pediatric.

Etanercept is a soluble form of a tumor necrosis factor receptor. It was first approved in 1998 for patients with moderate-to-severe rheumatoid arthritis. Etanercept was approved in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis; in 2002 to treat psoriatic arthritis; in 2003 to treat patients with ankylosing spondylitis; and in 2004 to treat moderate-to-severe plaque psoriasis in adults. Etanercept is administered by injection.

Source: Amgen; March 10, 2016.