Arcutis Presents Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast
Arcutis and Sato today announced that the companies have entered into a strategic collaboration and licensing agreement for topical roflumilast in Japan.
Journal of the American Academy of Dermatology Publishes ZORYVE Results
Arcutis today announced the launch of ZORYVE® (roflumilast) topical foam, 0.3%, in the United States for the treatment of seborrheic dermatitis
WESTLAKE VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new individual patient response data showing the vast majority of individuals (91.5%) treated with investigational roflumilast cream 0.15% had a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks. New pooled analyses from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu, HI. Roflumilast cream 0.15% is a once-daily, steroid-free cream being investigated for adults and children 6 years of age and older with atopic dermatitis.
WESTLAKE VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a new subgroup analysis highlighting that adults and adolescents with seborrheic dermatitis who are contraindicated, intolerant, or unresponsive to topical steroids were 3.5 times more likely to achieve IGA Success with ZORYVE® (roflumilast) topical foam, 0.3%, compared to vehicle (78.8% ZORYVE foam; 48.3% vehicle; p<0.001)i. ZORYVE foam is a once-daily steroid-free topical for use in all skin and hair types that effectively clears and controls seborrheic dermatitis. Data were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu.
Arcutis` Zoryve has snagged a 2nd dermatology nod from FDA
FDA has set a PDUFA target action date of July 07, 2024Atopic dermatitis affects approximately 16.5 million adults and 9.6 million children in the United StatessNDA supported by positive efficacy and...
New individual patient response data showed nearly all individuals (95%) treated with ZORYVE® (roflumilast) cream 0.3% had a measurable improvement in PASI
Study met the primary endpoint and all secondary endpoints, highly consistent with rapid response from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trialsFor the primary endpoint, 25.4% of children...