FDA Accepts sNDA for Roflumilast Cream 0.05% in Infants With Atopic Dermatitis Down to 3 Months
INTEGUMENT-INFANT showed 49.1% achieving vIGA-AD clear/almost clear at week 4 and 27.3% meeting vIGA-AD Success, alongside rapid pruritus improvement.
FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis Down to Age 2
Indication expansion addresses a major pediatric gap where topical corticosteroids are commonly used off-label yet constrained by sensitive-site and long-term continuous-use limitations.
Arcutis Launches New Virtual Health Platform Supporting Access to Care for Individuals Living with Chronic Inflammatory Skin Diseases, Including Approved ZORYVE® (roflumilast) Indications
Virtual health platform offers an additional pathway to care for the more than 45 million people in the U.S. living with eczema, seborrheic dermatitis, and plaque psoriasis.
FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Arcutis 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
If approved, ZORYVE cream would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2.
Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress
Once-daily, steroid-free roflumilast foam 0.3% demonstrated significant improvements in both scalp and body psoriasis
