Arcutis Biotherapeutics

Patrick Burnett emphasizes the importance of diversity in clinical trials, highlighting the need for subgroup-specific data to ensure safety and efficacy across different patient types. He discusses upcoming trials for roflumilast, focusing on younger age groups and the potential of non-steroidal treatments.

Bimzelx approved for 3 new indications by FDA; Arcutis Biotherapeutics' Zoryve foam accepted for scalp and body psoriasis; Rock4EB! concert raises $1M for EB research; semaglutide may reduce HS flare-ups; giant panda skin cells transformed into stem cells.

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 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.

Experts at the Skin of Color Update discussed recent FDA approvals for dermatology treatments, emphasizing the importance of clinical trial diversity. Key approvals included roflumilast and tapinarof for psoriasis, roflumilast for seborrheic dermatitis, and roflumilast for atopic dermatitis. Additionally, biologic therapies such as bimekizumab for psoriasis, secukinumab for hidradenitis suppurativa, and nemolizumab for prurigo nodularis were highlighted. The FDA is developing a diversity action plan to ensure more inclusive clinical trials.

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.