News from the FDA/CDC

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.

Purple FDA logo.
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.”

Recommended Reading

Debunking Psoriasis Myths: Does UVB Phototherapy Cause Skin Cancer?
MDedge Dermatology
Birth outcomes unaffected by paternal immunosuppressive therapy
MDedge Dermatology
Guselkumab achieves highest-ever response rates in psoriasis
MDedge Dermatology
Scalp Psoriasis: Weighing Treatment Options
MDedge Dermatology
Surgical Risks From Systemic Psoriasis Therapies
MDedge Dermatology
Secukinumab for psoriasis at 4 years: undiminished efficacy and safety
MDedge Dermatology
Tildrakizumab for psoriasis scores high marks in phase III
MDedge Dermatology
Erratum
MDedge Dermatology
PsA bone loss measurement: A surrogate for radiographic progression?
MDedge Dermatology
Close monitoring of psoriasis patients can delay PsA onset
MDedge Dermatology