Pharma Focus Europe

FDA Approves Arcutis' ZORYVE® (Roflumilast) Cream 0.3% for Psoriasis Treatment in Children Ages 6 to 11

Saturday, October 07, 2023

Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) is an early commercial-stage biopharmaceutical company with a focus on advancing innovations in immuno-dermatology. The company recently announced that the U.S. Food and Drug Administration (FDA) has granted approval for a supplemental new drug application (sNDA) to expand the indication of their product, ZORYVE (roflumilast) cream 0.3%. This expansion allows for the topical treatment of plaque psoriasis, including intertriginous areas, in children aged 6 to 11 years. ZORYVE is a steroid-free cream designed for once-daily use and is known for its effectiveness, safety, and high tolerance. It simplifies the management of plaque psoriasis.

Dr. Patrick Burnett, Chief Medical Officer at Arcutis, expressed the importance of this FDA decision, emphasizing the limited treatment options available for young children with plaque psoriasis. ZORYVE's safety, tolerability, and efficacy make it a valuable addition for managing this condition in pediatric patients.

Plaque psoriasis is the most common type of psoriasis in children aged 6 to 11 and shares clinical features with adult psoriasis, including raised, red skin areas covered with a silver or white layer of dead skin cells. However, treating plaques in sensitive areas presents specific challenges.

Dr. Adelaide A. Hebert, a pediatric dermatology expert, emphasized the need for steroid-free treatments for pediatric psoriasis, especially for sensitive areas like the face and skin folds. ZORYVE's clinical trials in the pediatric population demonstrated consistent efficacy and safety with results from adult trials.

ZORYVE is unique in its evaluation for efficacy in intertriginous areas (skin folds) during pivotal trials and its specific indication for use in these areas. It is a non-greasy, moisturizing cream that absorbs quickly and does not contain irritants or sensitizing agents like propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.

Leah M. Howard, President and CEO of the National Psoriasis Foundation, highlighted the challenges in treating pediatric psoriasis and expressed optimism about the advancements in alleviating the burden of the disease for this population.

The expanded FDA approval is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 6 to 11 with plaque psoriasis. The study's pharmacokinetic, safety, tolerability, and efficacy data align with results from the pivotal Phase 3 trials in adults. Future FDA reviews will consider data from a second MUSE study in children aged 2 to 5 years and an ongoing open-label extension study for long-term safety assessment in individuals with plaque psoriasis aged 2 and older (ARQ-151-306).

Psoriasis is a common immune-mediated skin disease affecting approximately nine million people in the United States, characterized by raised, red areas of skin covered with dead skin cells. Psoriasis plaques can be itchy, painful, and appear anywhere on the body, with unique treatment challenges in specific areas like the face, elbows, knees, scalp, and intertriginous areas.

ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients aged 6 years and older.

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