Arcutis Biotherapeutics has received US Food and Drug Administration (FDA) approval for the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3%, to treat seborrheic dermatitis in individuals aged nine-years and older.
ZORYVE foam offers quick disease clearance and major reduction in itch, with nearly 80% of individuals meeting the primary efficacy endpoint of IGA Success and just more than 50% of individuals achieving full clearance at Week 8 in the STRATUM trial.
A once-daily steroid-free foam, ZORYVE is claimed to be first drug approved in over twenty years for seborrheic dermatitis with a new mechanism of action.
Arcutis chief medical officer Patrick Burnett said: “We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use.
“ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. We are proud to deliver meaningful innovation through this approval of ZORYVE foam, and to offer a new topical treatment that effectively clears and controls the disease and can simplify its management for the millions of adults and adolescents living with seborrheic dermatitis.”
A common, chronic, and recurrent inflammatory skin disease, seborrheic dermatitis causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. It impacts over ten million people in the US.
It mostly occurs in areas of the body with oil-producing (sebaceous) glands, including the scalp, face, upper chest, and back. In the hair-bearing areas, applying topicals such as creams, gels, and ointments becomes difficult.
Arcutis plans to make ZORYVE foam widely available through major wholesaler and dermatology pharmacy channels by the end of January next year.