The FDA Just Approved a New Cream for Atopic Dermatitis

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According to the National Eczema Association, atopic dermatitis (AD) is the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States. “It’s a common chronic skin condition characterized by skin inflammation and itch,” says New York dermatologist Dr. Amy Spizuoco. “Atopic dermatitis can be difficult to manage, but it is treatable. Unfortunately, many people do not respond well to current treatments or lose treatment response over time, and as a result, they tend to cycle through therapies, underscoring the need for new treatment options.”

That’s where Opzelura (ruxolitinib) comes in: It’s a new topical cream that’s FDA-approved for the short-term and noncontinuous treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients age 12 and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

“Opzelura is the first and only topical JAK inhibitor approved in the United States, and research shows JAK signaling is important in immune function,” says Dr. Spizuoco. According to Incyte (Opzelura’s parent company), data reveals that the dysregulation of the JAK-STAT pathway contributes to key features of atopic dermatitis, such as itch, inflammation and skin barrier dysfunction that can be painful and frustrating.

However, some dermatologists are hesitant about the new drug, as the FDA labeled it with a black box warning—the same one used on oral JAK drugs—about serious infection, death, cancer, heart-related issues, and blood clots. “As a JAK inhibitor, I am aware of safety warnings for Opzelura, and I will carefully review risk factors with my patients to evaluate if this is appropriate therapy,” says Dr. Spizuoco. “Overall, this approval represents an important advancement for patients and their healthcare providers. We are fortunate to have a new treatment available, and I’m excited to have Opzelura as an option for some of my adolescent and adult patients with the disease.”

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