Dermatitis, Seborrheic

In the Phase III STRATUM trial, 80% of patients succeeded in the treatment by week eight using ZORYVE foam. Credit: Arcutis Biotherapeutics, Inc./GlobeNewswire. 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. See Also: FDA approves Astellas’ VYLOY for gastric cancer treatment Intercept’s liver disease drug Ocaliva faces FDA approval delay 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 .

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 once-daily simple application,” said Kim A. Papp, MD, PhD, of Probity Medical Research and K. Papp Clinical Research Inc., and an investigator for the ZORYVE foam clinical trials. “In the STRATUM trial, approximately 80% of patients achieved treatment success at Week 8 with ZORYVE foam, with disease clearance as early as Week 2, and significant itch relief in as little as 48 hours. Importantly, ZORYVE foam is formulated to deliver the drug without disrupting the skin barrier.” The approval of ZORYVE foam 0.3% for seborrheic dermatitis in Canada was supported by positive results from a vehicle-controlled pivotal Phase 3 study (STRATUM), as well as a Phase 2 study, a long-term open-label extension study, and a Phase 1 pharmacokinetic study. About ZORYVE FoamArcutis has developed both topical cream and foam formulations of roflumilast, a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. PDE4 — an established target in dermatology — is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. The approval of ZORYVE foam by Health Canada marks the second approval for Canada of the ZORYVE portfolio. Roflumilast cream 0.3% (PrZORYVE®) is approved in Canada for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio, including three FDA-approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions, including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. INDICATIONS (UNITED STATES)ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATION (UNITED STATES)ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the availability of roflumilast foam in Canada for the treatment of adults and adolescents with seborrheic dermatitis, the potential for roflumilast foam to enhance available options for seborrheic dermatitis, the potential to use roflumilast foam anywhere on the body, including the face and scalp, the potential treatment results based on real-world clinical practice, the potential to use roflumilast foam over a long period of time or chronically, and the potential for roflumilast foam to advance the standard of care in seborrheic dermatitis and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition, and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Corporate Controllerir@arcutis.com Blauvelt A, Draelos ZD, Stein Gold L, et al. Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial. J Am Acad Dermatol. 2024;90(5):986-993. doi:10.1016/j.jaad.2023.12.065Data on file. Arcutis Biotherapeutics, Inc.Jackson JM, Alexis A, Zirwas M, Taylor S. Unmet needs for patients with seborrheic dermatitis. J Am Acad Dermatol. 2024;90(3):597-604. doi:10.1016/j.jaad.2022.12.017

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalpSupplemental New Drug Application (sNDA) supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, and long-term ZORYVE cream plaque psoriasis program WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned the application a PDUFA target action date of May 22, 2025. “In clinical studies, investigational once-daily ZORYVE foam has demonstrated significant improvements in psoriasis signs and symptoms, effectively and reliably improving both scalp and body psoriasis across all efficacy endpoints compared to vehicle,” said Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and clinical trial investigator. “Almost half of individuals with plaque psoriasis experience it on their scalp, accompanied by itchy and sometimes painful plaques, often along with plaques elsewhere on the body. Scalp symptoms can be especially burdensome to manage because hair-bearing areas present unique challenges in terms of treatment application that are not easily addressed with traditional creams or ointments, as they can be inconvenient and messy when used to treat scalp psoriasis. The unique formulation of ZORYVE foam is potentially a transformative new treatment option, if approved, for those living with scalp and body psoriasis.” "ZORYVE foam, if approved, would represent a truly meaningful innovation for millions of people with scalp and body psoriasis whose symptoms have not been adequately addressed by existing treatments,” said Frank Watanabe, president and chief executive officer of Arcutis. “We look forward to working closely with the FDA during the review process for our fifth topical roflumilast regulatory submission in the United States in less than three years. This filing acceptance is a critical milestone in our mission to deliver new treatment options that address the urgent needs of individuals living with immune-mediated diseases and conditions.” The sNDA is supported by positive results from Arcutis’ pivotal ARRECTOR Phase 3 trial, a Phase 2b study, and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis. The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study was a parallel group, double-blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once-daily in individuals ages 12 and older with plaque psoriasis of the scalp and body (n=432). The study met its co-primary endpoints with 66.4% of individuals treated with roflumilast foam achieving Scalp-Investigator Global Assessment (S-IGA) Success (IGA Success is defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline) compared to 27.8% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001), and 45.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.1% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001). Two thirds (65.3%) of roflumilast-treated patients with clinically meaningful itch at baseline achieved a clinically significant reduction in itch compared to 30.3% of vehicle-treated patients at Week 8 (P<0.0001) as measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Importantly, some patients experienced rapid relief in scalp itch 24 hours following first application compared to vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=0.0164). In addition, improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS) was also observed at Week 8, with 63.1% of those treated with roflumilast foam achieving a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle (P<0.0001). Roflumilast foam 0.3% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, the most common adverse reactions for roflumilast foam in the phase 3 and phase 2b studies (≥1%) included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). Rates of discontinuation due to adverse events were low and similar among roflumilast-treated and vehicle-treated patients in pooled vehicle-controlled studies. About Scalp and Body Psoriasis Scalp psoriasis is a manifestation of plaque psoriasis and sometimes extends to the forehead, back of the neck, or behind or inside the ears. Plaque psoriasis is characterized by raised, red areas of skin (“plaques”) covered with a silver or white scale. Individuals with scalp psoriasis commonly have plaques on other areas of the body as well. Almost half of the estimated 9 million Americans with plaque psoriasis have scalp involvement. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is further complicated by the need to deliver drugs onto the affected skin in hair bearing areas where traditional cream and ointment formulations can be difficult to apply. As with psoriatic plaques on other parts of the body, psoriasis on the scalp is often itchy and is sometimes painful. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. Often, individuals require two or more medications to manage their disease when they have scalp involvement. About ZORYVE (roflumilast) FoamRoflumilast foam is a once-daily topical foam formulation of roflumilast, a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast foam is uniquely formulated for use anywhere on the body, including hair-bearing areas. ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses. IndicationsZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full prescribing information for ZORYVE foam and full prescribing information for ZORYVE cream. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential of roflumilast foam and regulatory timing for FDA approval based on the PDUFA for the treatment of scalp and body psoriasis; the potential of real-world use results of roflumilast foam, as well as the potential approval of roflumilast foam for scalp and body psoriasis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Corporate Controllerir@arcutis.com