Eucrisa Gains FDA Approval for Atopic Dermatitis
The Food and Drug Administration (FDA) has approved Eucrisa (crisaborole ointment; Pfizer) for the treatment of mild to moderate atopic dermatitis in patients aged ≥2 years.
Current treatment options for atopic dermatitis include combinations of antibiotics, antihistamines, topical corticosteroids, and topical immunomodulators. Eucrisa is a non-steroidal, topical anti-inflammatory phosphodiesterase 4 (PDE-4) inhibitor that is applied twice daily. Its specific mechanism of action is not completely established but it is presumed to work by inhibiting PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.
The safety and efficacy was evaluated in two Phase 3 placebo-controlled trials (n=1,522) with patients aged 2–79 years who had mild to moderate atopic dermatitis. Those treated with Eucrisa had greater response with clear or almost clear skin after 28 days of treatment. Eucrisa should not be used in patients with a hypersensitivity reaction to crisaborole. The most common adverse event was application site pain, including burning or stinging.
Eucrisa will be available as a 2% ointment.
For more information call (650) 543-7500 or visit Pfizer.com.