Pfizer's Atopic Dermatitis Drug Cibinqo Label Expanded In U.S. To Include Adolescents

(RTTNews) - The U.S. Food and Drug Administration approved Pfizer Inc.'s (PFE) supplemental New Drug Application or sNDA for Cibinqo (abrocitinib), expanding its indication to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Cibinqo was previously approved only for the treatment of adults 18 years and older.

Cibinqo is an oral inhibitor of Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

To date, Cibinqo has received marketing authorization in the U.S., the European Union, Great Britain, and other countries, and has launched in Germany, Japan, China, and more than 20 other markets worldwide.

Atopic dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Most people know atopic dermatitis is a skin condition, but many don't realize it can be caused in part by an abnormal immune response beneath the skin.

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