FDA Approves Abrocitinib for Moderate to Severe AD

Abrocitinib, an oral selective Janus kinase 1 inhibitor, received FDA approval for the treatment of moderate to severe atopic dermatitis (AD) in adults whose disease was not adequately controlled with other systemic therapies.

The oral agent should be initially dosed at 100 mg, but 200 mg may be recommended for patients who do not have an adequate response to the 100 mg dose. An additional 50 mg dose may be used to treat AD in patients with moderate renal impairment, patients receiving treatment with anti-cytochrome P450 (CYP) 2C19 agents, or patients who are known or suspected to poorly metabolize CYP2C19, though 100 mg may be prescribed if there is no response.

Approval follows the analysis of 5 clinical trials involving more than 1600 patients. The trials evaluated various measures, including improvements in skin clearance, disease extent, and severity. In the phase 3 clinical trials, at least 24% and 38% of patients who received either 100 mg or 200 mg, respectively, of abrocitinib achieved an Investigator Global Assessment score of clear or almost clear after 12 weeks. Further, at least 40% and 61% of patients, respectively, also achieved an 75% reduction from baseline Eczema Area and Severity Index.

The safety of abrocitinib was consistent across all trials, with common adverse events of nasopharyngitis, nausea, and headache. Abrocitinib will have a black box warning regarding increased risk of infections, all-cause mortality, malignancy, major cardiovascular events, and thrombosis.

Reference
U.S. FDA approves Pfizer's CIBINQO^® (abrocitinib) for adults with moderate-to-severe atopic dermatitis. Press release. Pfizer; January 14, 2022. Accessed January 14, 2022. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults