FDA approves abrocitinib in adolescents with atopic dermatitis

A supplemental New Drug Application (sNDA) for abrocitinib (CIBINQO; Pfizer) in adolescents has been approved by the US Food and Drug Administration.

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for abrocitinib (CIBINQO; Pfizer) for use in pediatric patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD).

Abrocitinib is an oral medication that inhibits Janus kinase (JAK) 1. JAK1 inhibition has been associated with improved outcomes for AD, modulating cytokines such as interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

AD is caused by an abnormal immune response beneath the skin and is characterized by skin inflammation and skin barrier defects. This can lead to discolored skin patches, itching, lichenification, oozing, and induration. It is one of the most common inflammatory skin diseases, affecting about 11% of children in the United States.

Abrocitinib is now approved for use in adolescents when AD cannot be controlled with other therapies because of inadequate outcomes or inadvisable use of these therapies. The expanded approval followed the JADE TEEN trial, a phase 3, randomized, placebo-controlled study.

The administration of 100 mg and 200 mg doses of abrocitinib in adolescents were analyzed in the JADE TEEN trial. Participants presented with moderate-to-severe AD and were taking topical medications. Improvements in skin clearance, itch, disease extent, and severity were measured.

Abrocitinib was taken by participants once per day, with patients receiving either a 100 mg or 200 mg dose. One group of patients received a placebo dose daily instead. The initial treatment period lasted 12 weeks, with patients given the option to enroll in a long-term extension study.

A consistent safety profile was reported, along with improvements in disease severity, disease extent, and skin clearance. Common adverse events included nasopharyngitis, nausea, and headache.

“This is a meaningful advancement for the many adolescents across the US who are affected by the persistent itching and discomfort that accompanies uncontrolled moderate-to-severe atopic dermatitis,” said Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital.


FDA approves Pfizer's supplemental new drug application for CIBINQO® (abrocitinib). Business Wire. February 10, 2023. Accessed February 13, 2023. https://www.businesswire.com/news/home/20230210005281/en/FDA-Approves-Pfizers-Supplemental-New-Drug-Application-for-CIBINQO%C2%AE-abrocitinib

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