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Friday, Apr 19, 2024

Arcutis Gets FDA Nod for Topical Foam

Westlake Village-based immunodermatology company Arcutis Biotherapeutics Inc. has received approval from the Food and Drug Administration for a topical foam version of its main drug to treat seborrheic dermatitis in individuals aged 9 and older. The approval, announced last month, marks the first new method of application for a drug to treat seborrheic dermatitis in more than 20 years. 

Seborrheic dermatitis is a chronic recurrent inflammatory skin disease that affects more than 10 million people in the United States. In most people, it is marked by red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. It occurs most often in areas of the body with oil-producing glands, including the scalp, face, upper chest, and back. Hair-bearing areas make applying topicals like creams, gels and ointments difficult.

Arcutis’ breakthrough drug roflumilast is a phosphodiesterase-4 inhibitor that increases the body’s production of one enzyme that blocks the body’s inflammation response and decreases production of another enzyme that boosts the body’s inflammation response. In July 2022, the FDA  approved a cream formulation of the drug, which is marketed under the name Zoryve, to treat plaque psoriasis in patients age 6 and older.

But topical creams are hard to apply in areas of the body that have a lot of hair or are hard to reach. That prompted Arcutis to develop a foam that uses a propellant to enable the drug to be applied in hard-to-reach places. This allows the drug to be used for seborrheic dermatitis, which often thrives in these areas.

“We are thrilled with this FDA approval and are excited to bring to market a new, highly effective steroid-free topical formulation that can be used anywhere on the body,” said Frank Watanabe, chief executive of Arcutis. “Our commercial team is ready and poised to launch Zoryve foam very soon, and we are committed to ensuring affordable access to Zoryve foam to those who may benefit from this novel treatment.”

James Brock
James Brock
James Brock has worked in newsrooms around the world, including in New York, Paris, Abu Dhabi, Dubai, Houston, and Los Angeles. He began his career with a Newhouse News daily, where he served on the news desk and the editorial page. He was the copy chief for The New York Sun, and founded and edited the personal finance section for Abu Dhabi-based The National, among other positions. He has interviewed Anthony Bourdain, Tom Ford, Mark Cuban, and many other individuals, and has written and edited thousands of stories and articles.

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