FDA Approves Pfizer’s Supplemental New Drug Application for CIBINQO® (abrocitinib)

Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved its supplemental New Drug Application (sNDA) for CIBINQO® (abrocitinib), expanding its indication to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis (AD) 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.

“This is a meaningful advancement for the many adolescents across the U.S. 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 in San Diego. “The extended indication of CIBINQO offers potential relief for young atopic dermatitis patients in need and their families.”

The CIBINQO prescribing information was updated to include data from JADE TEEN, a Phase 3, randomized, placebo-controlled clinical trial. JADE TEEN, which supported the expanded indication, evaluated both the 100 mg and 200 mg doses of CIBINQO versus placebo in adolescents 12 to <18 years of age with moderate-to-severe AD while also on background therapy with topical medications. The trial evaluated measures of improvements in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment (IGA), Peak Pruritus Numerical Rating Scale (PP-NRS), and Eczema Area and Severity Index (EASI).

“Moderate-to-severe atopic dermatitis can have debilitating physical and emotional impacts on adolescents,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “As an efficacious once-daily pill, we believe that CIBINQO offers an important new treatment option for adolescents burdened by uncontrolled symptoms of atopic dermatitis. Encouraged by an increasing uptake in the adult population, we look forward to bringing this important new oral medicine to adolescents who have yet to find relief from this inflammatory skin condition with current options.”

Data from the robust clinical trial program included in the prescribing information now stems from five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with CIBINQO. Across the trials to date, CIBINQO demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo, including adolescents.

Across trials, the most common adverse events reported in ≥1% of patients treated with CIBINQO for up to 16 weeks included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7% with CIBINQO 200 mg, and 7.9% with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

Additional Details on the JADE TEEN Clinical Trial

  • JADE TEEN: A randomized, double-blind, placebo-controlled, parallel group study. A total of 285 individuals 12 to <18 years of age with moderate-to-severe atopic dermatitis were randomized to receive once-daily abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 12 weeks while also on background topical therapy. Eligible subjects completing the 12-week treatment period of the study had the option to enter a long-term extension (LTE) study, B7451015. The trial assessed the co-primary endpoints of IGA 0 or 1 and EASI-75 responses at Week 12.
    Select findings from JADE TEEN are as follows:
    • IGA 0 or 1 Response Rate (Week 12): 39% with CIBINQO 100 mg, 46% with CIBINQO 200 mg, and 24% with placebo
    • EASI-75 Response Rate (Week 12): 64%, 71%, and 41%, respectively
    • Proportion of participants achieving PP-NRS at least a 4-point decrease from baseline (Week 2): 13%, 25%, and 8%, respectively
    • Safety profile seen in JADE TEEN was consistent with the pivotal trials and findings for the adult population

About CIBINQO® (abrocitinib)
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 ≥20 other markets worldwide.

About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.1,2 Most people know AD is a skin condition, but many don’t realize it can be caused in part by an abnormal immune response beneath the skin. This dysregulated immune response is thought to contribute to inflammation within the skin and the signs of AD on the surface. Lesions of AD are characterized by erythema (red/pink or discolored skin patches, depending on normal skin color), itching, lichenification (thick/leathery skin), induration (hardening)/papulation (formulation of papules), and oozing/crusting.1,2

AD is one of the most common inflammatory skin diseases, affecting approximately 5-10% of adults in the U.S. and approximately 11% of children in the U.S.1,2,3,4,5 Approximately 1 in 3 adults and 1 in 3 children and adolescents, 17 and under, with AD have moderate-to-severe disease.6,7

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