FDA: Etanercept first biologic approved for pediatric psoriasis

Etanercept has been received Food and Drug Administration approval for treating chronic moderate to severe plaque psoriasis in children and adolescents, aged 4-17 years, making this the first biologic and first systemic treatment approved in the United States for pediatric psoriasis.

Etanercept manufacturer, Amgen, announced the FDA approval in a press release on Nov. 4. Approval was based on the results of 1-year data and 5-year open label extension results of a phase III study in patients aged 4-17 years, with chronic moderate to severe plaque psoriasis, according to the release.

Etanercept, a tumor necrosis factor blocker marketed as Enbrel, was approved in 1998 for treating moderately to severely active rheumatoid arthritis and has been approved for several other indications since then, including psoriatic arthritis and moderate to severe psoriasis in adults, and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.

James Heilman, MD/Wikimedia Commons

The prescribing information includes a boxed warning about the risk of serious infections associated with its use; that boxed warning also includes a statement that lymphoma and other malignancies, “some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.”

Etanercept has been received Food and Drug Administration approval for treating chronic moderate to severe plaque psoriasis in children and adolescents, aged 4-17 years, making this the first biologic and first systemic treatment approved in the United States for pediatric psoriasis.

Etanercept manufacturer, Amgen, announced the FDA approval in a press release on Nov. 4. Approval was based on the results of 1-year data and 5-year open label extension results of a phase III study in patients aged 4-17 years, with chronic moderate to severe plaque psoriasis, according to the release.

Etanercept, a tumor necrosis factor blocker marketed as Enbrel, was approved in 1998 for treating moderately to severely active rheumatoid arthritis and has been approved for several other indications since then, including psoriatic arthritis and moderate to severe psoriasis in adults, and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.

James Heilman, MD/Wikimedia Commons

The prescribing information includes a boxed warning about the risk of serious infections associated with its use; that boxed warning also includes a statement that lymphoma and other malignancies, “some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.”

Etanercept has been received Food and Drug Administration approval for treating chronic moderate to severe plaque psoriasis in children and adolescents, aged 4-17 years, making this the first biologic and first systemic treatment approved in the United States for pediatric psoriasis.

Etanercept manufacturer, Amgen, announced the FDA approval in a press release on Nov. 4. Approval was based on the results of 1-year data and 5-year open label extension results of a phase III study in patients aged 4-17 years, with chronic moderate to severe plaque psoriasis, according to the release.

Etanercept, a tumor necrosis factor blocker marketed as Enbrel, was approved in 1998 for treating moderately to severely active rheumatoid arthritis and has been approved for several other indications since then, including psoriatic arthritis and moderate to severe psoriasis in adults, and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.

James Heilman, MD/Wikimedia Commons

The prescribing information includes a boxed warning about the risk of serious infections associated with its use; that boxed warning also includes a statement that lymphoma and other malignancies, “some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.”