On January 14, 2022, the US FDA approved CIBINQO(R) (abrocitinib) oral tablets for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. CIBINQO, which is a Janus kinase (JAK) inhibitor, was approved based on results from 5 clinical trials demonstrating improvement in itching compared with placebo. CIBINQO carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Prescribing information can be found at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213871s000lbl.pdf
.
