CHMP recommends Staquis to treat atopic dermatitis.- Pfizer

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Staquis, intended for the treatment of atopic dermatitis. The applicant for this medicinal product is Pfizer Europe MA EEIG. Staquis will be available as 20 mg/g ointment. The active substance of Staquis is crisaborole, a non-corticosteroid dermatological agent for dermatitis, (ATC code: D11AH). Staquis is a phosphodiesterase?4 (PDE4) inhibitor that suppresses secretion of certain cytokines, such as tumour necrosis factor-? (TNF??), interleukins (IL?2, IL-4, IL-5), and interferon gamma (IFN?) and improves skin barrier function through its anti -inflammatory effects. The benefits with Staquis are its ability to provide clinical improvement in mild to moderate atopic dermatitis patients with less than 40% body surface area affected. The most common side effects are application site reactions, including application site pain, e.g., burning or stinging. Comment:crisaborole was approved in the USA on 14 December 2016 as Eucrisa.