Arcutis Biotherapeutics Submits FDA Application for ZORYVE Cream to Treat Plaque Psoriasis in Children

Arcutis Biotherapeutics has submitted a supplemental New Drug Application to the FDA for ZORYVE, a cream for treating plaque psoriasis in children as young as two years old. If approved, ZORYVE would be the first topical PDE4 inhibitor and an alternative to topical steroids and vitamin-D analogs. The application is based on positive long-term study results showing consistent favorable safety and efficacy across age ranges.

Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of ZORYVE cream 0.3% for the treatment of plaque psoriasis in children as young as two years old. If approved, ZORYVE would be the first topical PDE4 inhibitor and an alternative to topical steroids and vitamin-D analogs, offering an important treatment option for pediatric patients Arcutis Biotherapeutics Submits Supplemental New Drug Application to FDA For ZORYVE^[1].

The application is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study. The long-term study demonstrated consistent favorable long-term safety and tolerability, as well as persistence of efficacy across the age ranges studied Arcutis Biotherapeutics, Inc. Submits Supplemental New Drug Application for ZORYVE®? (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5^[2].

ZORYVE cream is uniquely formulated to be effective, safe, and well-tolerated for all areas of the body, including sensitive intertriginous skin where plaque psoriasis often presents in children. The cream can be used on sensitive areas, making it a valuable addition to the treatment options available for pediatric psoriasis patients.

Arcutis Biotherapeutics is a biopharmaceutical company focused on developing and commercializing treatments for dermatological diseases. The company's focus on pediatric dermatology is a significant advancement in the field, as current treatments for plaque psoriasis in children are limited.

The approval of ZORYVE cream would be a significant milestone for Arcutis Biotherapeutics and the broader dermatology community. It would provide a much-needed alternative to existing treatments, offering a safer and more effective option for pediatric psoriasis patients.

References:
Arcutis Biotherapeutics Submits Supplemental New Drug Application to FDA For ZORYVE^[1] https://finance.yahoo.com/news/arcutis-biotherapeutics-submits-supplemental-drug-042052954.html
Arcutis Biotherapeutics, Inc. Submits Supplemental New Drug Application for ZORYVE®? (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5^[2] https://www.marketscreener.com/news/arcutis-biotherapeutics-inc-submits-supplemental-new-drug-application-for-zoryve-roflumilast-c-ce7d59dbda88f027