European Commission approves Pfizer drug for adults with moderate-to-severe atopic dermatitis
pharmafile | December 14, 2021 | News story | Manufacturing and Production |
The EC has approved the investigational once-daily Janus kinase 1 (JAK1) inhibitor, abrocitinib, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. The oral drug, marketed as Cibinqo, has been approved in 100mg and 200 mg doses.
The approval was based on the results from five clinical studies of over 2,800 patients. These studies included four Phase III studies, and an ongoing long-term open label extension study. In these trials, Cibinqo demonstrated efficacy in relieving symptoms and controlling the disease in comparison to the placebo. Pfizer’s AD treatment also demonstrated a consistent safety profile across trials, including in a long-term extension study.
A 50 mg dose has additionally been approved to treat moderate-to-severe AD, specifically in patients with moderate and severe renal impairment (kidney failure), and some patients receiving treatment with inhibitors of cytochrome P450 (CUP) 2C19. Regulatory filing for the drug is already under priority review by the FDA.
“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,” shared 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.”
“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.”
Ana Ovey
