FDA Approves Expanded Indication for Abrocitinib to Include Adolescents With Atopic Dermatitis


Expanded indication for abrocitinib (Cibinqo; Pfizer Inc) includes patients 12 to <18 years of age with refractory, moderate-to-severe atopic dermatitis that is not adequately controlled with other systemic medications.

The FDA has approved a supplemental New Drug Application to expand the indication for abrocitinib (Cibinqo; Pfizer Inc) to include patients 12 to <18 years of age with refractory, moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with other systemic medications, including biologics, or when use of those therapies is inadvisable.

Abrocitinib is an oral Janus kinase (JAK) 1 inhibitor, which is hypothesized to modulate multiple cytokines involved in the pathophysiology of AD, including interleukins (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin. The JAK inhibitor was previously approved only for the treatment of patients with AD 18 years of age and older.

“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,” Lawrence Eichenfield, MD, chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital in San Diego, said in a press release. “The extended indication of Cibinqo offers potential relief for young atopic dermatitis patients in need and their families.”

The approval for the expanded indication for abrocitinib was based on data from the JADE TEEN phase 3 clinical trial, which analyzed both the 100 mg and 200 mg doses of abrocitinib compared with placebo. The investigators assessed 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).

The JADE TEEN trial randomized 285 patients, 12 to <18 years of age, with moderate-to-severe AD to receive once-daily abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 12 weeks while also receiving background topical therapy. Those who completed the 12-week treatment period had the option to enter B7451015, a long-term extension (LTE) study. The trial’s co-primary endpoints were IGA 0 or 1 and EASI-75 responses at Week 12.

The study showed that IGA 0 or 1 Response Rate (week 12) was 39% with abrocitinib 100 mg, 46% with abrocitinib 200 mg, and 24% with placebo, whereas the EASI-75 response rate was 64%, 71%, and 41%, respectively. The proportion of patients who achieved PP-NRS at least a 4-point decrease from baseline (week 2) was 13%, 25%, and 8%, respectively.

Clinical trial program data, which will now be added to the prescribing information, included findings from 5 randomized, placebo-controlled clinical trials and an LTE study that enrolled more than 1600 patients administered abrocitinib.

Across all trials to date, abrocitinib showed a consistent safety profile and significant improvements in skin clearance, extent of disease, and severity. The drug also produced rapid improvement in itch after 2 weeks for some patients with AD compared with placebo, including adolescents.

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

“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, in a press release. “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.”


FDA Approves Pfizer's Supplemental New Drug Application for CIBINQO® (abrocitinib). Pfizer. News release. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-supplemental-new-drug-application. Accessed February 13, 2023.

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