Arcutis Biotherapeutics said that its subsidiary, Arcutis Canada, has received regulatory approval from Health Canada for its Zoryve (roflumilast) topical foam 0.3%.
Zoryve is now approved in Canada for treating seborrheic dermatitis in patients aged nine and older.
The foam is said to be the first new topical treatment for seborrheic dermatitis approved in Canada in over 20 years. It features a new mechanism of action.
The product was approved by the US Food and Drug Administration (FDA) in December last year.
Arcutis Biotherapeutics president and CEO Frank Watanabe said: “Zoryve foam has made a meaningful impact on the lives of individuals living with seborrheic dermatitis since launching in the US at the beginning of this year, with rapid adoption by both clinicians and patients.
“We are proud to bring this safe, effective, and well-tolerated steroid-free foam to Canada, as there has been a lack of innovation for the treatment of seborrheic dermatitis for decades.”
“We would like to thank the Canadian investigators and patients who participated in our Zoryve clinical trials and who played a critical role in bringing this potential best-in-class topical treatment to the US and Canada markets.”
The approval of Zoryve foam 0.3% in Canada is backed by positive results from the vehicle-controlled Phase 3 STRATUM study.
It is also based on the findings from a Phase 2 study, a long-term open-label extension study, and a Phase 1 pharmacokinetic study.
In the STRATUM trial, the foam demonstrated rapid disease clearance by week two and significant itch relief within 48 hours. Nearly 80% of patients achieved the primary efficacy endpoint and over 50% of individuals completed clearance at week eight.
Additionally, the treatment reduced inflammation, redness, and scaling without disrupting the skin barrier.
The STRATUM study showed statistically significant improvement on all secondary endpoints, including itch, scaling, and erythema.
The foam was well-tolerated, demonstrating a favourable safety and tolerability profile over up to 52 weeks of treatment.
Another formulation of Zoryve, roflumilast cream 0.3%, is FDA-approved for the topical treatment of plaque psoriasis in individuals aged six and older. Zoryve cream, 0.15%, is authorised for atopic dermatitis in the US.
