FDA Approves Opzelura as Treatment for Atopic Dermatitis


In clinical trials, the majority of patients with atopic dermatitis treated with ruxolitinib had clear or almost clear skin.

The FDA has approved ruxolitinib (Opzelura, Incyte) cream for short-term, non-continuous treatment of mild to moderate atopic dermatitis in non-immunocompromised individuals 12 years of age or older whose disease is not controlled with topical prescription therapies, or when those therapies are not advisable.

Ruxolitinib is a topical formula of a Janus kinase (JAK) inhibitor that dysregulates the JAK-STAT pathway, which contributes to key features of atopic dermatitis, which causes itch, inflammation, and skin barrier dysfunction.

“Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage,” Jonathan Silverberg, MD, PhD, MPH, 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 press release. “Many patients do not respond well to existing treatments and have uncontrolled disease.”

The FDA approval was based on the Topical Ruxolitinib Evaluation in Atopic Dermatitis (TRuE-AD) clinical trial program, which consisted of 1200 adolescent and adult individuals with mild to moderate atopic dermatitis.

The results of the study showed individuals experienced clearer skin and itch reduction when treated with ruxolitinib cream with 1.5% twice a day, compared to the non-medicated cream.

At week 8, the ruxolitinib treatment groups in the TRuE-AD1 and True-AD2 trials had clear or almost clear skin at 53.8% and 51.3%, respectively, whereas the non-medicated cream group had 15.1% and 7.6% clearer or almost clear skin, respectively, in TRuE-AD1 and True-AD2.

In TRuE-AD1 and True-AD2, at week 8, the reduction of itch was at 52.2% and 50.7%, respectively, in the ruxolitinib group, whereas the non-medicated group was at 15.4% and 16.3%, respectively.

The most common adverse reactions included nasopharyngitis, diarrhea, bronchitis, and ear infection.

“The approval of Opzelura is an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation,” Hervé Hoppenot, chief executive officer at Incyte, said in the release. “At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases.”

Atopic dermatitis can cause inflammation and itch. The symptoms include irritation and itchy skin that can cause red lesions that could ooze and crust.


Incyte announces US FDA Approval of Opzelura (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis. Business Wire. News release. September 21, 2021. Accessed September 22, 2021. https://www.businesswire.com/news/home/20210921006072/en

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