Arcutis Biotherapeutics, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) to expand the indication of ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, in children aged 6 to 11 years.
ZORYVE is a once-daily, steroid-free cream that offers an effective, safe, and well-tolerated treatment option, simplifying the management of plaque psoriasis in pediatric patients.
Dr. Patrick Burnett, Chief Medical Officer at Arcutis, emphasized the significance of this FDA decision, highlighting the lack of treatment options for young children with plaque psoriasis. ZORYVE has demonstrated its safety and efficacy, making it a valuable addition for the treatment of pediatric patients with plaque psoriasis.
Plaque psoriasis is the most common form of psoriasis in children aged 6 to 11, presenting with similar clinical features as in adults, including raised, red areas of skin covered with a silver or white layer of dead skin cells. However, treating plaques in sensitive areas, where the skin is thinner or more sensitive, can be challenging.
Dr. Adelaide A. Hebert, a pediatric dermatology expert, emphasized the need for steroid-free topical treatments for managing plaque psoriasis in children. Steroid-free options are particularly important for sensitive areas, where long-term use of topical steroids may raise safety and tolerability concerns.
ZORYVE is unique in that it is the only topical treatment evaluated for efficacy in intertriginous areas (skin folds) in pivotal trials, and it is specifically indicated for use in these areas. It is a non-greasy, moisturizing cream that absorbs quickly, making it suitable for sensitive skin.
Importantly, ZORYVE does not contain sensitizing excipients or irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.
Leah M. Howard, President, and CEO of the National Psoriasis Foundation, highlighted the significant impact of psoriasis on the quality of life for children and their caregivers. The Foundation is encouraged by advancements like the expansion of ZORYVE’s indication, which can alleviate the burden of this disease for pediatric patients.
The approval for this expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 6 to 11 with plaque psoriasis. Data from this study demonstrated consistency with the pivotal Phase 3 trials in adults, including pharmacokinetics, safety, tolerability, and efficacy.
Additional data from a study involving children aged 2 to 5, as well as an ongoing open-label extension study assessing the long-term safety of roflumilast cream 0.3% in individuals with plaque psoriasis aged 2 and older, will be subject to future FDA review.
Psoriasis is a prevalent immune-mediated skin condition, affecting around nine million individuals in the United States. It is important to note that psoriasis is non-contagious. The hallmark of psoriasis is the development of “plaques,” which are raised, red patches of skin covered with a silvery or white layer of dead skin cells.
These plaques may take on various shades, including grayish, purplish, or brownish tones in individuals with darker skin tones. Psoriatic plaques are often accompanied by itching and can be painful. They can manifest on any part of the body.
However, psoriasis can present unique challenges depending on the anatomical area affected. Some of these challenging areas include:
- Face: Psoriasis on the face can be particularly distressing due to its visibility. It may cause discomfort and impact an individual’s self-esteem.
- Elbows and Knees: Plaques in these joint areas can be especially stubborn and resistant to treatment. The constant bending and stretching of the skin can exacerbate the condition.
- Scalp: Scalp psoriasis can result in the development of scaly patches on the scalp, often accompanied by itching. This can lead to dandruff-like symptoms.
- Intertriginous Areas: These are regions where two skin surfaces come into contact or rub together, such as the armpits, under the breasts, groin, and folds of the stomach. Psoriasis in these areas can be challenging to manage due to the sensitivity and moisture of the skin, making it prone to irritation.
The treatment of psoriasis often requires a tailored approach, taking into account the specific location and severity of the plaques. Patients may receive various treatments, including topical creams, phototherapy (light therapy), or systemic medications, depending on the extent of their condition. Psoriasis management aims to alleviate symptoms, reduce inflammation, and improve the quality of life for individuals living with this chronic skin condition.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a pioneering medical dermatology company operating in the early commercial stage. The company is dedicated to advancing innovative solutions to address the pressing needs of individuals living with immune-mediated dermatological diseases and conditions. Arcutis is committed to resolving some of the most persistent challenges faced by patients in the field of dermatology.
Arcutis distinguishes itself through a unique dermatology development platform that combines cutting-edge science with a deep understanding of dermatological conditions. This platform serves as the foundation for developing therapies that target biologically validated molecular pathways and mechanisms underlying skin disorders.
The company’s diverse portfolio reflects its dedication to improving the lives of patients with various inflammatory dermatological conditions. This includes:
- Scalp and Body Psoriasis: Arcutis focuses on developing treatments for psoriasis affecting different areas of the body, including the scalp. Psoriasis is a chronic autoimmune skin condition characterized by the rapid buildup of skin cells, resulting in plaques, itching, and discomfort.
- Atopic Dermatitis: Arcutis is actively engaged in research and development efforts to address atopic dermatitis, a common and often chronic skin condition characterized by redness, itching, and inflammation. Also known as eczema, it can significantly impact a patient’s quality of life.
- Seborrheic Dermatitis: This skin condition involves the appearance of scaly, flaky, and often itchy skin, primarily affecting areas rich in oil glands like the scalp and face. Arcutis is working on therapies to manage seborrheic dermatitis effectively.
- Alopecia Areata: Alopecia areata is an autoimmune disorder that leads to hair loss on the scalp and other areas of the body. Arcutis is involved in research aimed at addressing this challenging condition.
Arcutis’ comprehensive pipeline includes multiple clinical programs tailored to these dermatological conditions. The company’s commitment to scientific innovation, combined with its dermatology expertise, positions it as a key player in the pursuit of novel therapies to improve the lives of individuals dealing with immune-mediated dermatological diseases.