EMA Panel Backs Crisaborole (Staquis) for Atopic Dermatitis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of crisaborole (Staquis, Pfizer) for the treatment of atopic dermatitis (eczema).

Crisaborole is a phosphodiesterase 4 (PDE-4) inhibitor that suppresses secretion of certain cytokines, such as tumor necrosis factor alpha, interleukins (IL-2, IL-4, IL-5), and interferon gamma and improves skin barrier function through its anti-inflammatory effects, the EMA notes in a statement.

Crisaborole is indicated for the treatment of mild to moderate atopic dermatitis in adults and in children as young as age 2 years with ≤40% body surface area affected. Once approved, it will be available as a 20-mg/g ointment.

The most common side effects are application site reactions, including pain, burning, or stinging. Crisaborole should be prescribed by physicians experienced in the treatment of atopic dermatitis, the EMA said.

Detailed recommendations for the use of crisaborole will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

Crisaborole (sold as Eucrisa) was approved by the US Food and Drug Administration in 2016 for the treatment of mild to moderate atopic dermatitis in patients aged 2 years or older, as reported by Medscape Medical News.

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