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Arcutis Announces Health Canada Approval of ZORYVE® (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older
ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades1Second
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"ZORYVE foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades1Second approval of ZORYVE outside of the United States, expanding ZORYVE portfolio availability to over 2 million Canadians living with seborrheic dermatitis WESTLAKE VILLAGE, Calif., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older. The full Canadian product monograph for ZORYVE is available here. Over 2 million Canadians are impacted by seborrheic dermatitis, a common, recurrent inflammatory skin condition. ZORYVE foam 0.3% is the first topical treatment for seborrheic dermatitis with a novel mechanism of action approved in Canada in over 20 years.1 “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,” said Frank Watanabe, president and CEO of Arcutis. “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.” “For individuals living with this chronic, inflammatory skin condition, seborrheic dermatitis can have a profound impact on quality of life. The face and scalp are often red and scaly, which may result in social distancing and consequently affects emotional and psychological wellbeing. Itch, commonly associated with seborrheic dermatitis, may not be apparent through the day but will impair sleep resulting in sleep deprivation. Until today, we lacked the ability to offer effective and safe treatments that are formulated to be both well-tolerated and suitable for o...