European Commission Approves Pfizer’s Cibinqo (abrocitinib) for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis

Pfizer Inc. announced that the European Commission (EC) has approved the 100 mg and 200 mg doses of Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate and severe renal impairment (kidney failure) or certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19.

“For adults living with moderate-to-severe atopic dermatitis, Cibinqo could help provide relief from the hallmark symptom of intense itch and has demonstrated rapid improvements in skin clearance, extent, and severity of disease, versus placebo,” said Dr. Stephan Weidinger, Professor of Dermatology at Christian-Albrechts University Kiel and Vice Head of the Department of Dermatology at the University Hospital Schleswig-Holstein, Kiel, Germany. “The approval of Cibinqo in the European Union makes me hopeful for many patients who will have this additional option to help manage the often painful and disruptive symptoms of moderate-to-severe atopic dermatitis.”

The approval of Cibinqo was based on the results of five clinical studies of more than 2,800 patients including four Phase 3 studies and an ongoing long-term open label extension study. Cibinqo demonstrated meaningful improvements across measures of symptom relief and disease control versus placebo. In one trial including an active control arm with dupilumab, which evaluated patients on background topical medicated therapy, Cibinqo 200 mg was associated with a greater improvement in itch relief after two weeks than dupilumab. Cibinqo also demonstrated a consistent safety profile across trials, including in a long-term extension study, showing a favorable benefit-risk profile.

“There have been few treatment innovations over the last decade for those in the European Union suffering with the daily discomfort, distress, and pain caused by moderate-to-severe atopic dermatitis,” said Mike Gladstone, Global President of Pfizer Inflammation & Immunology. “The safety and efficacy established through a rigorous clinical trial program, designed to evaluate measures of symptom relief most important to patients, gives us great confidence in the positive impact Cibinqo could have on those living with this debilitating immuno-inflammatory condition.”

The most common adverse events reported with Cibinqo in ≥5% of patients were nausea (15.1%) and headache (7.9%). The most frequent serious adverse reactions were infections (0.3%).