Arcutis Biotherapeutics has been granted approval by the US Food and Drug Administration (FDA) for the use of its ZORYVE (roflumilast) topical foam, 0.3% in individuals with seborrheic dermatitis.

The latest approval for ZORYVE is for the treatment of the recurrent inflammatory skin disease in individuals aged nine and older, said the Nasdaq-listed immuno-dermatology company.

Previously, ZORYVE was approved by the regulator for its topical use in treating plaque psoriasis, encompassing intertriginous areas, in patients aged six and older. The approval was for its roflumilast cream formulation.

ZORYVE foam and cream are both topical formulations containing roflumilast, a potent and selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an intracellular enzyme known to enhance the production of pro-inflammatory mediators while reducing the production of anti-inflammatory mediators, making it a well-established target in dermatology.

According to Arcutis Biotherapeutics, ZORYVE foam offers swift disease clearance and substantial itch reduction.

The once-daily foam is now the first drug to be approved for the treatment of seborrheic dermatitis with a novel mechanism of action in more than 20 years, said the company.

Arcutis Biotherapeutics expects to make the product commercially available by the end of next month.

Arcutis Biotherapeutics 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.”

The drug’s approval in seborrheic dermatitis has been driven by the results from its Phase 2 and Phase 3 trials in seborrheic dermatitis.

The STRatum study and Phase 2 trial were both parallel-group, double-blind, vehicle-controlled studies assessing the safety and effectiveness of ZORYVE foam 0.3%. Collectively, the two studies included 683 adults and adolescents aged nine years and older.

The primary endpoint was achieved in the STRATUM study, where almost 80% of individuals treated with ZORYVE foam attained the investigator global assessment (IGA) Success rate by Week 8.

In the Phase 2 trial, 73% of individuals treated with ZORYVE foam reached IGA Success, defined as an IGA score of “Clear” (0) or “Almost Clear” (1), along with a 2-grade improvement in IGA score from baseline at Week 8.