Arcutis Biotherapeutics announces U.S. FDA accepted sNDA for roflumilast cream

Arcutis Biotherapeutics announced the U.S. Food and Drug Administration, FDA, has accepted its supplemental new drug application, sNDA, for roflumilast cream 0.15% for the treatment of atopic dermatitis, AD, in adults and children down to age 6. Roflumilast cream is a once-daily, steroid-free, phosphodiesterase-4 inhibitor. The FDA assigned the application a Prescription Drug User Fee Act ,PDUFA, target action date of July 07, 2024. “With this filing acceptance, we are one step closer to potentially providing a new topical option for the millions of Americans living with atopic dermatitis. Given the prevalence of this disease in both children and adults, as well as the need for better long-term management, we believe once-daily, steroid-free roflumilast cream has the potential to become the new standard of care in atopic dermatitis,” said Frank Watanabe, president and chief executive officer at Arcutis. “We look forward to working closely with the FDA during the review process as part of our ongoing efforts to develop topical roflumilast for the treatment of immune-mediated skin diseases.” The sNDA is supported by positive results from three Phase 3 programs as well as a Phase 2 dose ranging study, and two Phase 1 pharmacokinetic studies. INTEGUMENT-1 and INTEGUMENT-2 were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD. Roflumilast met its primary endpoint with a validated Investigator Global Assessment – Atopic Dermatitis Success rate of 32.0% compared to a vehicle rate of 15.2%, and 28.9% compared to a vehicle rate of 12.0% at Week 4, in INTEGUMENT-1 and -2, respectively. Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch-Numeric Rating Scale Success at Week 4, with rapid and significant improvements observed as early as 24 hours following the first application. In addition, more than 40% of children and adults treated with roflumilast cream achieved a 75% reduction in Eczema Area and Severity Index at Week 4 compared to vehicle with significant results observed as early as Week 1 in both studies. Roflumilast cream 0.15% was well tolerated.