- FDA has set a PDUFA target action date of July 07, 2024
- Atopic dermatitis affects approximately 16.5 million adults and 9.6 million children in the United States
- sNDA supported by positive efficacy and safety data from the pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials
WESTLAKE VILLAGE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today 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 (PDE4) inhibitor. The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.
“Atopic dermatitis is a chronic and recurring inflammatory skin condition that requires therapy that is effective, tolerable, and suitable for long-term use by both adults and children. Due to its waxing and waning nature, long-term disease control is ideal for the patient versus cyclical treatment, which consists of starting and stopping treatment when skin is controlled and when it is not,” said Lawrence Eichenfield MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, professor of dermatology and pediatrics and vice-chair of the Department of Dermatology at UC San Diego School of Medicine, and study investigator. “In clinical trials, roflumilast cream demonstrated rapid and sustained improvement in the signs and symptoms of disease, as well as long-term proactive disease control with twice weekly maintenance dosing. With this profile, patients will not need to make tradeoffs between long-term safety, efficacy, and tolerability. Roflumilast cream if approved, has the potential to simplify the approach to disease control for children and adults.”
“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 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) 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 (vIGA-AD) Success rate of 32.0% compared to a vehicle rate of 15.2% (P