Arcutis Updates on sNDA for Roflumilast Cream 0.15% for Atopic Dermatitis

WESTLAKE VILLAGE, Calif., July 09, 2024 — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a biopharmaceutical enterprise specializing in immuno-dermatology solutions, has engaged in discussions with the U.S. Food and Drug Administration (FDA) concerning its supplemental New Drug Application (sNDA) for roflumilast cream 0.15%. This topical treatment is targeted at alleviating mild to moderate atopic dermatitis (AD) in both adults and children aged six and above. The FDA has communicated that they are in the process of finalizing the action letter and do not foresee extending the Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2024.

Frank Watanabe, president and CEO of Arcutis, highlighted the FDA's lack of requests for additional information, indicating the thoroughness and quality of the company's submission. "We have rigorously ensured that all necessary data and regulatory requirements are met," Watanabe stated. "Our ongoing communications with the FDA reinforce our anticipation of receiving the action letter imminently. Upon approval, we are eager to offer this innovative roflumilast cream to those affected by atopic dermatitis."

Arcutis Biotherapeutics, Inc. focuses on meaningful innovation in the field of medical dermatology to address critical needs in immune-mediated dermatological conditions. The company boasts a growing portfolio that includes two FDA-approved products. These products leverage Arcutis’ unique dermatology development platform and extensive expertise, leading to the creation of differentiated therapies aimed at biologically validated targets.

Arcutis’ dermatology development platform supports a robust pipeline featuring multiple clinical programs. These programs target a variety of inflammatory dermatological conditions, such as scalp and body psoriasis, atopic dermatitis, and alopecia areata. The company remains dedicated to solving persistent challenges faced by patients in dermatology.

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