Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over

Rhea-AI Summary

Arcutis Biotherapeutics (Nasdaq: ARQT) has submitted a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) foam to the FDA for treating scalp and body psoriasis in adults and adolescents ages 12 and over. The once-daily foam significantly improved both scalp and body psoriasis in Phase 2b and Phase 3 trials, with 67% of participants achieving Scalp-Investigator Global Assessment Success at 8 weeks. The treatment also showed rapid reduction in scalp itch within 24 hours and demonstrated a favorable safety profile.

This submission marks Arcutis' fifth topical roflumilast regulatory submission in the U.S. in less than three years. The company believes ZORYVE foam has great potential for adoption in scalp and body psoriasis, building on its success in seborrheic dermatitis treatment.

Positive

• Submission of sNDA for ZORYVE foam to treat scalp and body psoriasis
• 67% of participants achieved Scalp-Investigator Global Assessment Success at 8 weeks
• Rapid reduction in scalp itch observed within 24 hours
• Favorable safety and tolerability profile demonstrated
• Fifth topical roflumilast regulatory submission in less than three years

Negative

• None.

Insights

Medical Research Analyst

The submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam is a significant milestone in medical dermatology. The clinical data reveal that ZORYVE foam effectively treats both scalp and body psoriasis, with 67% of participants achieving Scalp-Investigator Global Assessment Success at 8 weeks. This rapid efficacy, including relief from scalp itch within 24 hours, indicates a robust potential for improving patient outcomes. Given that 40% of the 9 million individuals with plaque psoriasis in the U.S. experience scalp involvement, the broad applicability of ZORYVE foam could address a substantial unmet need. Notably, the safety and tolerability profile further supports its use in a diverse patient population, including adolescents 12 years and older.

Market Research Analyst

From a market perspective, ZORYVE foam's approval could considerably boost Arcutis Biotherapeutics' market share in the immuno-dermatology sector. The existing success of ZORYVE foam in treating seborrheic dermatitis suggests a strong adoption potential for scalp and body psoriasis. This expansion aligns with a broader trend towards non-steroidal treatments in dermatology, which are increasingly preferred due to fewer side effects. Additionally, Arcutis' track record of rapid regulatory submissions and strategic execution enhances its credibility and positions it as a leader in the field. Investors should anticipate a favorable market reaction if the FDA approval is granted.

Financial Analyst

Financially, the approval of ZORYVE foam for scalp and body psoriasis could significantly enhance Arcutis Biotherapeutics' revenue streams. The company's ability to secure five regulatory submissions in the U.S. within three years demonstrates operational efficiency and strategic foresight. The potential market for ZORYVE foam is substantial, considering the 9 million individuals affected by plaque psoriasis in the U.S., with 40% experiencing scalp involvement. Approval could lead to rapid market penetration and adoption, bolstering Arcutis' financial performance. Investors should monitor the FDA's decision closely, as approval could act as a catalyst for the stock.

• Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp
  
• Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial
• Data also show rapid reduction in scalp itch as soon as 24 hours after first application
• ZORYVE foam demonstrated a favorable safety and tolerability profile

WESTLAKE VILLAGE, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (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.

“Nearly half of all individuals with plaque psoriasis have involvement of the scalp. Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking,” said Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology, investigator with Probity Medical Research, and clinical trial investigator. “Clinical data show that investigational once-daily ZORYVE foam effectively and reliably cleared both scalp and body psoriasis across all efficacy endpoints compared to vehicle, including 67% of participants achieving Scalp-Investigator Global Assessment Success with ZORYVE foam at 8 weeks. These data demonstrate that ZORYVE foam, if approved, would be an important new treatment option for those living with psoriasis.”

"This important milestone represents our fifth topical roflumilast regulatory submission in the United States in less than three years and brings another innovative treatment to the large population of individuals with scalp and body psoriasis. Based on the rapid adoption of ZORYVE foam in seborrheic dermatitis due to the simplicity of using one treatment anywhere on the body, including hair-bearing areas, we believe there is great potential for its adoption in scalp and body psoriasis, once approved,” said Frank Watanabe, president and chief executive officer of Arcutis. “Our team’s ability to execute our clinical development and commercial strategies reinforces Arcutis’ leadership in medical dermatology and positions the ZORYVE portfolio as a new standard of care for the effective treatment of multiple immune-mediated, chronic skin diseases. I would like to thank the clinical investigators, study coordinators, patients, and caregivers who participated in our clinical trials.”

About the Data
The submission 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 with plaque psoriasis of the scalp and body ages 12 and older (n=432). The study met its co-primary endpoints with 67.3% 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 28.1% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001), and 46.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.8% 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 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), as well as Week 2 (the earliest timepoint measured).

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 (1.8%) and vehicle-treated (1.3%) patients.

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. Approximately 40% of the estimated 9 million Americans with plaque psoriasis have involvement of the scalp. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is complicated by the difficulty of delivering 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) Foam
Roflumilast foam is a once-daily topical foam formulation of roflumilast, a next generation topical phosphodiesterase-4 (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.

Indications
ZORYVE 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 Arcutis
Arcutis 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 Statements
Arcutis 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 to simplify disease management 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:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Latha Vairavan, Vice President, Finance and Investor Relations
lvairavan@arcutis.com

FAQ

What is the purpose of Arcutis' sNDA submission for ZORYVE foam?

Arcutis submitted a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam to treat scalp and body psoriasis in adults and adolescents ages 12 and over.

What were the key results from the clinical trials for ZORYVE foam (ARQT)?

In clinical trials, 67% of participants achieved Scalp-Investigator Global Assessment Success with ZORYVE foam at 8 weeks. The treatment also showed rapid reduction in scalp itch within 24 hours and demonstrated a favorable safety profile.

How many regulatory submissions has Arcutis (ARQT) made for topical roflumilast?

This sNDA submission marks Arcutis' fifth topical roflumilast regulatory submission in the United States in less than three years.

What is the potential market for ZORYVE foam in psoriasis treatment?

Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp, indicating a significant potential market for ZORYVE foam in psoriasis treatment.