The US Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ once-daily steroid-free foam, Zoryve (roflumilast), to treat seborrhoeic dermatitis in patients aged nine years and older. 

Affecting more than ten million people in the US, seborrhoeic dermatitis is a common, chronic and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales and persistent itch.

It occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face, upper chest and back.

Arcutis’ Zoryve is now the first drug approved for seborrhoeic dermatitis with a new mechanism of action in over two decades.

The FDA’s decision was supported by positive results from mid- and late-stage trials in seborrhoeic dermatitis. This included the phase 3 STRATUM study, in which nearly 80% of Zoryve foam treated-patients achieved the primary endpoint of Investigator Global Assessment (IGA) success, which was defined as an IGA score of clear or almost clear, at week eight. 

Zoryve foam was also associated with disease clearance as early as week two in the STRATUM study, as well as statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling and erythema (redness).

Commenting on the approval, Arcutis’ chief medical officer, Patrick Burnett, said: “We know from dermatology clinicians and those living with seborrhoeic 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."

"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 seborrhoeic dermatitis,” he added.