Arcutis Biotherapeutics, Inc. has launched a new virtual health platform designed to expand access pathways to its ZORYVE portfolio for chronic inflammatory skin diseases. The platform connects individuals with independent, board-certified dermatologists through a streamlined digital experience for evaluation and to discuss potential treatment options. This initiative aims to address barriers such as long wait times and geographic limitations for the more than 45 million people in the U.S. living with eczema, seborrheic dermatitis, and plaque psoriasis.

The virtual health platform provides an additional pathway to care for individuals who have yet to see a dermatologist or who struggle with obtaining timely dermatology care. It is designed to complement traditional in-office dermatology specialist care by offering a convenient alternative. After completing a brief clinical intake, individuals are connected with independent dermatologists who evaluate, diagnose, and determine appropriate treatment based on their clinical judgment.

Arcutis does not influence clinical decision-making, diagnoses, or prescribing decisions made through the platform. If prescribed, ZORYVE prescriptions are coordinated through a national pharmacy hub designed to support a seamless experience, including insurance support and home delivery. Alternatively, prescriptions can be sent directly to an individual’s preferred pharmacy.

ZORYVE Portfolio Indications

ZORYVE is a topical formulation of roflumilast, a targeted topical phosphodiesterase type 4 (PDE4) inhibitor. The portfolio includes several approved indications across different age groups and conditions:

Strategic Commitment

The launch of the virtual health platform reflects Arcutis’ broader commitment to improving access to care and treatment for individuals living with chronic inflammatory skin diseases. Todd Edwards, chief commercial officer of Arcutis, stated that the platform is designed to help reduce barriers to specialist treatment and support individuals who may otherwise forego or face delays in seeing a dermatologist. The company continues to engage healthcare providers across dermatology, primary care, and pediatric settings to support patient care.

Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.3% to treat plaque psoriasis in children as young as 2 years old. This approval expands the indication for the once-daily, steroid-free topical therapy, which is now suitable for use anywhere on the body with no restrictions on duration of use. The decision addresses a significant treatment gap for young children with a chronic, immune-mediated inflammatory skin disease. ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved for this patient population.

The FDA approval is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216) evaluating ZORYVE cream 0.3% in children ages 2 to 5 years with plaque psoriasis. The open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy in children with plaque psoriasis involving at least 2% body surface area. Supportive long-term safety data came from an open-label extension study (ARQ-151-306), which evaluated the treatment for up to 24 weeks.

Frank Watanabe, president and chief executive officer of Arcutis, stated that the approval demonstrates the company's commitment to delivering meaningful innovation to the youngest children and their families. ZORYVE cream 0.3% is a potent and selective PDE4 inhibitor. This marks the seventh FDA approval for the ZORYVE portfolio in four years.

ZORYVE cream 0.3% was previously approved for the treatment of plaque psoriasis in adults and children down to age 6. The therapy is widely available via key wholesaler and dermatology pharmacy channels. Arcutis offers the ZORYVE Direct Program to help patients navigate insurance and reduce out-of-pocket costs, as well as the Arcutis Cares patient assistance program for eligible uninsured or underinsured patients.

Key Indications for ZORYVE