Topical Ruxolitinib Gains FDA Approval for Atopic Dermatitis

The FDA announced the approval of topical ruxolitinib for the treatment of atopic dermatitis (AD) in patients aged 12 years and older. The cream, the first Janus kinase (JAK) inhibitor in a topical formulation, has been indicated for the short-term and noncontinuous chronic treatment of mild to moderate AD.

The approval comes after promising results from two randomized, double-blind, vehicle-controlled phase 3 studies (TRuE-AD 1 and TRuE-AD 2). The studies, which included more than 1200 adolescents and adults with mild to moderate AD, demonstrated significant improvement in skin appearance and itch when treated with topical ruxolitinib 1.5% twice daily vs vehicle.  Specifically, more than 51% of patients achieved at least a 2-point improvement in Investigator Global Asssessment compared with control (<15.1%) in both trials. Patients who applied topical ruxolitinib also experienced a clinically meaningful reduction in itch by week 8 of treatment.

Treatment-emergent adverse events of the experimental arm included nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea. Topical ruxolitinib will have a black box warning regarding serious infections, malignancy, cardiovascular events, and mortality.

Reference
Incyte announces U.S. FDA approval of Opzelura™ (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis (AD). Press release. Incyte; September 21, 2021. Accessed September 21, 2021. https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura-ruxolitinib-Cream-a-Topical-JAK-Inhibitor-for-the-Treatment-of-Atopic-Dermatitis-AD/default.aspx