Key Takeaways:
Arcutis Biotherapeutics Inc. won U.S. Food and Drug Administration approval to expand use of its Zoryve (roflumilast) cream 0.3% to children as young as 2 with plaque psoriasis, the company said Monday, marking the seventh FDA clearance for the topical therapy in four years.
"This approval provides physicians and caregivers a targeted topical therapy that can be used anywhere on the body for any duration of time," Lisa Swanson, a board-certified pediatric dermatologist and clinical trial investigator at Ada West Dermatology, said in a statement.
The supplemental new drug application was supported by a four-week maximal usage systemic exposure study in 2- to 5-year-olds with plaque psoriasis involving at least 2% body surface area, along with open-label extension data covering up to 24 weeks of treatment. Results showed safety and efficacy profiles consistent with the pivotal Phase 3 DERMIS-1 and DERMIS-2 trials in adolescents and adults. Common adverse reactions included diarrhea (3.1%), headache (2.4%), insomnia (1.4%), and nausea (1.2%).
Zoryve is a once-daily, steroid-free phosphodiesterase-4 inhibitor that can be applied anywhere on the body, including sensitive areas such as the face and skin folds, with no restrictions on duration of use. The expanded indication addresses a treatment gap for young children who previously had limited options appropriate for long-term use, particularly on sensitive skin where topical steroids are not recommended.
"Parents and caregivers of young children with plaque psoriasis have faced a significant treatment gap for years, with very limited options," Leah Howard, president and chief executive officer of the National Psoriasis Foundation, said.
The approval extends Zoryve's label from the prior minimum age of 6 down to age 2. Arcutis shares closed at $26.76 on Monday, down 0.89%, paring gains from a nearly 95% rally over the past 12 months. The stock remains near its 52-week high of $31.77, with a market capitalization of about $3.4 billion.
Zoryve is the top prescribed branded topical therapy across plaque psoriasis, atopic dermatitis, and seborrheic dermatitis combined, according to the company. Arcutis reported revenue of $415.6 million over the trailing 12 months, up 95%, with gross profit margins of 91%.
The expanded pediatric label opens a new patient population for Arcutis at a time when the company is navigating the end of a co-promotion deal with Kowa Pharmaceuticals that has clouded near-term revenue visibility. The approval gives Arcutis a first-mover advantage in the youngest psoriasis segment, where no other non-steroidal topical was previously available. Investors will watch prescription trends and insurance coverage decisions in the coming quarters as a gauge of commercial uptake.
This article is for informational purposes only and does not constitute investment advice.
