Arcutis Biotherapeutics' Foam Psoriasis Treatment Receives FDA Approval

Arcutis Biotherapeutics has received FDA approval for its foam psoriasis treatment, ZORYVE. The topical cream is a once-daily formulation of roflumilast, a PDE4 inhibitor. The company's pipeline also includes ARQ-255 for alopecia areata, ARQ-252 for chronic hand eczema and vitiligo, and ARQ-234 for psoriasis.

Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has received FDA approval for its ZORYVE topical foam 0.3% formulation for the treatment of plaque psoriasis in patients aged 12 and older. This marks the company's fifth FDA approval for ZORYVE in under three years, further expanding its psoriasis portfolio.

ZORYVE is a once-daily, steroid-free topical treatment that demonstrated significant efficacy in clinical trials. The foam formulation addresses the needs of over half of the 9 million U.S. psoriasis patients who experience scalp involvement. In the pivotal ARRECTOR trial, 66.4% of patients achieved Scalp-IGA Success and 45.5% achieved Body-IGA Success at Week 8. The treatment also showed rapid itch relief within 24 hours and a strong safety profile with only mild to moderate adverse events [1].

The approval of ZORYVE foam expands Arcutis' psoriasis portfolio, targeting an underserved segment of the psoriasis market – patients with scalp and hair-bearing areas involvement. The foam formulation offers convenience of application in hair-bearing areas, a steroid-free formulation allowing for unrestricted long-term use, and rapid relief of itch – the most burdensome symptom reported by psoriasis patients. Arcutis has strategically positioned ZORYVE with two complementary formulations (cream and foam), creating a versatile franchise that can treat psoriasis anywhere on the body [1].

Arcutis has established patient support programs (ZORYVE Direct and Arcutis Cares) to address access barriers, which is critical for commercial uptake in the competitive dermatology space. With this fifth FDA approval in under three years, Arcutis is establishing itself as a significant player in immuno-dermatology with a growing commercial footprint [1].

References:
[1] https://www.stocktitan.net/news/ARQT/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-6bqvminynrsq.html