The approval from the European Commission (EC) is based on the results of five clinical studies, involving over 2,800 patients.
The European Commission has approved the 100mg and 200mg 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.
A 50mg dose has also been approved to treat moderate-to-severe atopic dermatisis, specifically in patients with moderate and severe renal impairment (kidney failure), or certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19.
This EC approval was based on the results of five clinical studies, including four phase 3 studies and an ongoing long-term open-label extension study. These studies included over 2,800 patients and Cibinqo demonstrated meaningful improvements across measures of symptom relief and disease control versus placebo. In one study, which included an active control arm with dupilumab, which evaluated patients on background topical medicated therapy, a 200mg dose of Cibinqo 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.
Atopic dermatitis is a chronic inflammatory skin disease, characterised by intense itching, skin dryness and rashes.
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, Germany, commented: “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. 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.”