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Recently, Pfizer stated in a statement that the European Commission has approved Cibinqo (abrocitinib) in 100 mg and 200 mg doses for the treatment of moderate to severe atopic dermatitis in adults suitable for systemic therapy.
Cibinqo's approval is mainly based on the results of five clinical studies conducted on more than 2,800 patients, including four phase 3 studies and an ongoing long-term open label extension study. The results of the trial showed that compared with placebo, Cibinqo showed significant improvement in symptom relief and disease control. In a trial that included an active control group using dupilumab, the trial evaluated patients on background topical medications. Compared with dupilumab, 200 mg of Cibinqo had a greater improvement in itch relief after two weeks. These trials evaluated the improvement effect of atopic dermatitis, and the evaluation indicators included the global assessment (IGA), the eczema area and severity index (EASI), and the peak pruritus digital rating scale.
In addition, Cibinqo also demonstrated consistent safety characteristics derived from multiple trials, including in long-term extended studies, showing favorable benefit-risk characteristics. The most common (≥5%) adverse events reported by Cibinqo in patients were nausea (15.1%) and headache (7.9%), and the most common serious adverse reaction was infection (0.3%).
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