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The FDA Greenlights Arcutis Biotherapeutics’ Revolutionary Treatment for Scaly Skin Disorder FDA Approves Arcutis Biotherapeutics’ Lead Drug For Scaly Skin Disorder

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The FDA has given the nod to Arcutis Biotherapeutics Inc‘s astonishing ARQT’s Zoryve (roflumilast) topical foam, 0.3% for seborrheic dermatitis in individuals nine years and older. 

Unveiling as a once-daily steroid-free foam, Zoryve is the first drug sanctioned for seborrheic dermatitis with a new mechanism of action in over two decades.

More than 10 million individuals in the U.S. grapple with seborrheic dermatitis, a relentless inflammatory skin disease that generates red patches draped with large, greasy, flaking yellow-gray scales along with persistent itch.

In the STRATUM trial, Zoryve foam exhibited rapid disease clearance as early as Week 2 and remarkable itch relief in as little as 48 hours. Additionally, nearly 80% of patients achieved treatment success at Week 8. 

Arcutis is gearing up to unleash Zoryve foam widely through key wholesaler and dermatology pharmacy channels as a fresh treatment option by the conclusion of January 2024. 

In September, Arcutis Biotherapeutics unwrapped data from the INTEGUMENT-PED Phase 3 trial of roflumilast cream 0.05% in children ages 2 to 5 years with mild to moderate atopic dermatitis. 

For the primary endpoint, 25.4% of children treated once daily with roflumilast cream achieved Investigator Global Assessment Success compared to 10.7% of children treated with the vehicle at Week 4, with substantial enhancements glimpsed as early as Week 1.

Zoryve cream is approved for topical treatment of plaque psoriasis, including intertriginous areas, in patients six years and older.

Price Action: ARQT shares have burgeoned by 22.54% to $2.99 during the premarket session based on the last update check on Monday.

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