Arcutis Gets Health Canada Nod for ZORYVE® Foam to Treat Seborrheic Dermatitis in Ages 9+

Arcutis Biotherapeutics, Inc., a biopharmaceutical company specializing in immuno-dermatology, has announced that its subsidiary, Arcutis Canada, Inc., has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3%. This approval is for treating seborrheic dermatitis in patients aged 9 years and older. The approval marks a significant milestone as ZORYVE foam represents the first new topical treatment mechanism for seborrheic dermatitis approved in Canada in over two decades. Over 2 million Canadians are affected by this common inflammatory skin condition.

Seborrheic dermatitis is a chronic skin disorder characterized by red, scaly patches primarily on the face and scalp. This condition can severely impact the quality of life, leading to social isolation and affecting both emotional and psychological well-being. The itch associated with seborrheic dermatitis can cause sleep disturbances, adding to the burden of the disease. Until now, there has been a void in the availability of effective and safe treatments that are easy to apply and well-tolerated.

Frank Watanabe, president and CEO of Arcutis, expressed the company's pride in bringing this innovative steroid-free foam to Canada. He highlighted the significant impact ZORYVE foam has had in the United States since its launch earlier this year, noting rapid adoption by both clinicians and patients. He also thanked Canadian investigators and patients who participated in the ZORYVE clinical trials, underscoring their critical role in bringing this potentially best-in-class treatment to market.

Dr. Kim A. Papp, a leading investigator in the ZORYVE foam clinical trials, emphasized the profound impact of seborrheic dermatitis on patients' lives. He noted that the STRATUM trial demonstrated significant results, with about 80% of patients achieving treatment success by Week 8, visible disease clearance as early as Week 2, and significant itch relief within 48 hours. Importantly, ZORYVE foam is designed to deliver the drug effectively without disrupting the skin barrier.

The approval of ZORYVE foam 0.3% in Canada is based on positive results from several studies, including a pivotal Phase 3 study (STRATUM), a Phase 2 study, a long-term open-label extension study, and a Phase 1 pharmacokinetic study.

ZORYVE foam is a topical formulation of roflumilast, a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an established target in dermatology, known for its role in increasing pro-inflammatory mediators and decreasing anti-inflammatory mediators. The approval of ZORYVE foam by Health Canada marks the second approval for the ZORYVE portfolio in Canada. Roflumilast cream 0.3% is already approved in Canada for the topical treatment of plaque psoriasis in patients 12 years and older.

Arcutis Biotherapeutics, Inc. is dedicated to developing innovative therapies for immune-mediated dermatological diseases. The company's dermatology development platform includes a robust pipeline with multiple clinical programs targeting various inflammatory skin conditions, such as scalp and body psoriasis, atopic dermatitis, and alopecia areata. Arcutis aims to address the most persistent challenges in dermatology and provide meaningful solutions for patients.

The approval of ZORYVE foam 0.3% for seborrheic dermatitis offers a new and effective treatment option for Canadian patients, providing relief from a condition that significantly impacts their quality of life. This advancement represents a significant step forward in the treatment of seborrheic dermatitis and highlights Arcutis' commitment to bringing innovative dermatology solutions to market.