Arcutis Biotherapeutics' subsidiary, Arcutis Canada, has received Health Canada's approval for ZORYVE (roflumilast) topical foam 0.3%, to treat seborrheic dermatitis in patients aged nine years and above.
This is the second international approval of ZORYVE, offering a new treatment option to the more than two million Canadians affected by the chronic skin condition.
The approval was based on positive outcomes from the pivotal Phase III STRATUM study, along with results from a Phase II long-term open-label extension trial study and a Phase I pharmacokinetic clinical trial.
In the vehicle-controlled STRATUM trial, 80% of patients succeeded in the treatment by week eight using ZORYVE foam, with some experiencing disease clearance as early as week two.
The foam can provide significant itch relief within 48 hours due to its formulation, designed to administer the medicine effectively without troubling the skin barrier.
ZORYVE foam 0.3% is the first topical medication with a new mechanism of action for seborrheic dermatitis approved in Canada in more than two decades.
Arcutis president and CEO Frank Watanabe stated: “ZORYVE foam has made a meaningful impact on the lives of individuals living with seborrheic dermatitis since launching in the United States 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 United States and Canada markets.”
Roflumilast, the active ingredient in ZORYVE, is a highly potent and selective inhibitor of Phosphodiesterase-4 (PDE4), an enzyme known to modulate inflammatory responses in the skin.
Arcutis has developed roflumilast’s cream as well as foam formulations to treat dermatologic conditions.
The US Food and Drug Administration (FDA) had previously approved ZORYVE foam 0.3% for seborrheic dermatitis in December 2023.
The FDA also approved ZORYVE cream for atopic dermatitis in July 2024.
