FDA Approves Topical JAK inhibitor for Atopic Dermatitis

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.

The FDA has approved Incyte’s Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of atopic dermatitis such as itch, inflammation, and skin barrier dysfunction.

The FDA approval was based on data from two phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelura in more than 1,200 adolescents and adults. Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily, compared with a non-medicated cream. Significantly more patients treated with Opzelura experienced a clinically meaningful reduction in itch from baseline at Week 8.

The most common adverse reactions were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, and tonsillitis.

“Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease,” Jonathan Silverberg, M.D., Ph.D., M.P.H., associate professor of dermatology and director of clinical research and contact dermatitis at The George Washington University School of Medicine and Health Sciences, said in a statement.

Opzelura is a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib.

Atopic dermatitis is a chronic skin disease affecting more than 21 million people aged 12 years and older in the United States and is characterized by inflammation and itch.