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Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
FDA has set a target action date of December 16, 2023NDA supported by positive efficacy and safety data from the Phase 2 and pivotal Phase 3 trials of
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"FDA has set a target action date of December 16, 2023NDA supported by positive efficacy and safety data from the Phase 2 and pivotal Phase 3 trials of roflumilast foamIf approved, roflumilast foam would be the first topical drug for seborrheic dermatitis with a new mechanism of action in over two decades WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023. “Seborrheic dermatitis has long been a disease in need of its own treatment,” said Neal Bhatia MD, Director of Clinical Dermatology at Therapeutics Clinical Research and one of the investigators for Arcutis. “Some of the biggest challenges of current treatments have not only been lack of efficacy and consequences from long-term use, but also the limitations that affect adherence, especially the inability to treat both hair- and non-hair-bearing areas. Roflumilast foam was designed to address these shortcomings, as a once-daily, steroid-free topical drug that can be used chronically anywhere on the body. Dermatologists will be excited to incorporate roflumilast foam, if approved, as a new standard of care for those living with seborrheic dermatitis.” Roflumilast foam is an investigational once-daily, topical formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk. Seborrheic dermatitis affects more than 10 million people in the U.S., and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. Seborrheic dermatitis occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back. “The acceptance of the NDA f...