European Commission approves Pfizer’s Cibinqo to treat adults with moderate-to-severe atopic dermatitis
Cibinqo is a once-daily oral treatment with proven efficacy demonstrated in a large-scale clinical trial programme
Pfizer Inc yesterday 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 in adults who are candidates for systemic therapy. Additionally, a 50 mg dose was approved to treat moderate-to-severe atopic dermatitis specifically in patients with moderate and severe renal impairment (kidney failure) or certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, the company notified via a statement.
“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, Dermatology, Christian-Albrechts University Kiel, and Vice Head, Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.
According to the statement, the approval of Cibinqo was based on the results of five clinical studies of more than 2,800 patients including four phase-III 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 favourable 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, Pfizer Inflammation and Immunology.
The most common adverse events reported with Cibinqo in ≥5 per cent of patients were nausea (15.1 per cent) and headache (7.9 per cent). The most frequent serious adverse reactions were infections (0.3 per cent), the statement concluded.