- FDA has set a target action date of December 16, 2023
- NDA supported by positive efficacy and safety data from the Phase 2 and pivotal Phase 3 trials of roflumilast foam
- If 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 for roflumilast foam marks a major milestone toward our goal of bringing a steroid-free, topical foam treatment option to market, addressing a significant unmet need for individuals living with seborrheic dermatitis,” said Frank Watanabe, President and CEO of Arcutis. “If approved, roflumilast foam would be the first topical drug with a new mechanism of action for this condition in over two decades, highlighting the unique formulation and deep dermatological expertise that Arcutis brings to immuno-dermatology. We look forward to continuing our work with the FDA over the coming months and are preparing commercial efforts for the anticipated approval and launch.”
The NDA is supported by positive results from Arcutis’ Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was the pivotal Phase 3, parallel group, double-blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3% in seborrheic dermatitis. The STRATUM study met its primary endpoint with an Investigator Global Assessment (IGA) Success rate of 79.5% in roflumilast foam-treated individuals compared to 58.0% (P