European Commission Approves Pfizer's Cibinqo for Moderate-to-Severe Eczema

The European Commission has approved Pfizer's Cibinqo® (abrocitinib) in 100 mg and 200 mg doses for adults suffering from moderate-to-severe atopic dermatitis who are candidates for systemic therapy. The medication is an oral, once-daily Janus kinase 1 (JAK1) inhibitor.

The approval is based on the results of five clinical studies involving over 2,800 patients. In these trials, Cibinqo demonstrated meaningful improvements in symptom relief and disease control compared to placebo. One study, which included an active comparator (dupilumab), showed that Cibinqo 200 mg provided faster itch relief at two weeks than dupilumab.

The clinical trial program, JADE (JAK1 Atopic Dermatitis Efficacy and Safety), encompassed four Phase 3 studies and an ongoing long-term extension study. The findings indicated that Cibinqo can provide relief from intense itching and improve the appearance and severity of skin lesions.

Commonly reported adverse events with Cibinqo included nausea (15.1%) and headache (7.9%). Serious adverse reactions were infrequent, with infections reported in 0.3% of patients.

Pfizer states that the approval of Cibinqo offers a new treatment option for European patients experiencing the painful and disruptive symptoms of moderate-to-severe atopic dermatitis. A 50 mg dose has also been approved for patients with moderate-to-severe renal impairment or those receiving treatment with certain CYP2C19 inhibitors.