FDA Approves Pfizer's CIBINQO® for Adults with Moderate-to-Severe Atopic Dermatitis
The U.S. Food and Drug Administration (FDA) has approved Pfizer's CIBINQO® (abrocitinib) for adults with moderate-to-severe atopic dermatitis. The approval offers a new oral treatment option for patients who have not found relief with prior therapies.
Pfizer Inc.'s CIBINQO® (abrocitinib) has received approval from the United States Food and Drug Administration (FDA) for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD). This approval marks a new oral therapy option for patients whose disease is not adequately controlled by other systemic treatments, including biologics, or when those therapies are not advisable.
CIBINQO is a once-daily oral Janus kinase 1 (JAK1) inhibitor. The FDA approved the drug at recommended doses of 100 mg and 200 mg, with the 200 mg dose suggested for patients not responding to the 100 mg dose. A 50 mg dose was also approved for specific patient groups, including those with moderate renal impairment or receiving certain medications that inhibit CYP2C19.
The FDA's decision was informed by results from five clinical trials involving over 1,600 patients. Across these studies, CIBINQO demonstrated a consistent safety profile and significant improvements in skin clearance, disease extent, and severity. Notably, a rapid improvement in itch was observed for some patients within two weeks of treatment compared to placebo.
Pfizer stated that CIBINQO will become available in the U.S. in the coming weeks. The approval is expected to provide a new therapeutic avenue for millions of Americans experiencing the debilitating symptoms of atopic dermatitis, such as intense itching, pain, and discomfort.