FDA Approves Expanded Use Of Arcutis Biotherapeutics' Eczema Drug For Patients As Young As 6 Years

On Tuesday, the FDA approved Arcutis Biotherapeutics Inc’s ARQT supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for mild to moderate atopic dermatitis in patients six years of age and older.

“Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream 0.15% as a new steroid-free treatment option to children and adults living with AD,” said Frank Watanabe, president and CEO of Arcutis.

Arcutis intends to make Zoryve cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July.

In the first quarter of 2024, the Zoryve franchise generated sales of $21.6 million, with $15 million for Zoryve cream, 0.3%, and $6.5 million for Zoryve topical foam, 0.3%; sales growth was 675% year over year and 59% sequentially.

Results from three Phase 3 studies, a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies support the sNDA.

INTEGUMENT-1 and INTEGUMENT-2 phase 3 trials met their primary endpoint of IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear plus a 2-grade improvement from baseline.

• Individuals treated with Zoryve cream experienced rapid and significant improvement in itch within 24 hours of the first application.
• In addition, over 40% of children and adults treated with Zoryve cream achieved a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 compared to vehicle.
• In both studies, significant improvements based on EASI-75 were observed with ZORYVE cream compared to the vehicle as early as Week 1.

Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.

Roflumilast cream for atopic dermatitis is currently being evaluated at a lower dose of 0.05% for children aged 2 to 5 years.

In addition, Arcutis has completed its clinical development program for Zoryve foam 0.3% for scalp and body psoriasis and intends to submit an sNDA in the third quarter of 2024.

Price Action: ARQT shares were down 5.29% to $9.49 at the last check on Wednesday.

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