Breaking News: FDA Approves Opzelura™ (Ruxolitinib) Cream


By National Eczema Association

Published On: Sep 21, 2021

Last Updated On: Nov 18, 2021

Today the eczema community is one step closer to having a new treatment option. The U.S. Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream, from manufacturer Incyte, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age 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 formulation of a JAK inhibitor approved in the United States. Opzelura will be available by prescription only.

The inflammation of AD is caused in part by immune system messengers called cytokines that are increased in the blood and the skin. Several of these inflammatory cytokines exert their effects through a chemical signal pathway inside cells known as the JAK-STAT pathway (Janus Kinase-Signal transducer and activators of transcription). Opzelura works by selectively blocking pathways that drive inflammation, itch and skin barrier dysfunction in AD.

It’s important to talk to your doctor about how AD affects your skin and other aspects of your life. Together, you and your healthcare provider can determine if Opzelura is an appropriate treatment option.

Visit our New Prescription Treatment hub to learn more about Opzelura and other new therapies as they are available.

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