FDA accepts supplemental BLA for Enbrel for treating pediatric patients with psoriasis

Amgen announced in a press release that the FDA has accepted to review its supplemental biologics license application for expanding the use of Enbrel to treat pediatric patients with chronic severe plaque psoriasis.

Results from a phase 3, 1-year study and a 5-year, open-label extension study to measure the safety and efficacy of Enbrel (etanercept) as treatment for pediatric patients with moderate-to-severe plaque psoriasis were used in the supplemental biologics license application (BLA), according to the release. Etanercept is a soluble form of a tumor necrosis factor receptor.

“If approved, Enbrel would be the first systemic drug approved in the U.S. to treat chronic severe plaque psoriasis in pediatric patients,” Sean E. Harper, MD, executive vice president of research and development at Amgen, stated in the release. “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 approved for treating moderate-to-severe rheumatoid arthritis, moderate-to severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and moderate-to-severe plaque psoriasis in adults, according to the release.

Patients treated with etanercept are at increased risk for developing serious infections, and most patients who developed the infections were taking concomitant immunosuppressants, including methotrexate or corticosteroids, the release reported. Active tuberculosis (TB), including reactivation of latent TB, have been reported infections, according to the release.

Reference: www.amgen.com