Roflumilast

Zelsuvmi's approval for molluscum contagiosum tops Healio's most-read FDA approvals in dermatology for 2024, with other notable approvals including Xeomin, Klisyri, Zoryve, and more.

James Del Rosso, DO, discussed new medications at the 44th Annual Fall Clinical Dermatology Conference, focusing on topical agents like ruxolitinib (Opzelura) and roflumilast (Zoryve), highlighting their efficacy and safety for conditions such as atopic dermatitis and vitiligo.

Arcutis Canada received Health Canada approval for ZORYVE foam to treat seborrheic dermatitis in patients aged nine and above, based on positive Phase III STRATUM trial results. ZORYVE foam offers rapid itch relief and is the first topical treatment with a new mechanism of action for seborrheic dermatitis in Canada in over two decades.

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FDA sets PDUFA target action date for ZORYVE foam for scalp and body psoriasis treatment to May 22, 2025. ZORYVE foam, a PDE4 inhibitor, demonstrated significant efficacy in Phase 2b and Phase 3 trials. Almost half of U.S. plaque psoriasis patients have scalp involvement, presenting unique treatment challenges.

FDA accepts Arcutis Biopharmaceutical's sNDA for Zoryve (roflumilast) 0.3% foam to treat scalp and body psoriasis, with a PDUFA date set for May 22, 2025. The approval is based on ARRECTOR phase 3 study data showing 65.3% of patients achieved clinically meaningful itch reduction by week 8. Common adverse reactions include headaches, diarrhea, and nausea.

FDA accepted Arcutis' sNDA for roflumilast foam 0.3% (Zoryve) to treat scalp and body psoriasis in adults and adolescents aged 12+. The decision is based on positive ARRECTOR phase 3 trial results, showing significant itch reduction and good tolerability. The FDA target action date is May 22, 2025.

FDA accepts roflumilast foam 0.3% sNDA for treating scalp and body psoriasis in individuals aged 12 and older, with a PDUFA date of May 22, 2025. Clinical trials showed significant improvements in psoriasis signs and symptoms, with 66.4% achieving Scalp-IGA Success and 45.5% achieving Body-IGA Success. Common adverse reactions include headache, diarrhea, nausea, and nasopharyngitis.

FDA approves Arcutis' Zoryve (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis in adults and children from 6 years old, offering a once-daily, steroid-free option with rapid disease clearance and significant itch reduction.