The FDA approved Arcutis Biotherapeutics’ skin treatment Zoryve to treat mild to moderate atopic dermatitis in adults and some children, the company announced Tuesday.
It’s the drug’s third approval in two years, and the second as a once-daily topical cream. Zoryve, a PDE4 inhibitor, was first approved as a cream in July 2022 to treat plaque psoriasis. The new label includes adults and children 6 years and older.
“Having a new and effective steroid-free option, without some of the risks associated with topical and systemic steroids, is a welcome advancement for dermatologists, patients, and caregivers,” Lawrence Eichenfield, an investigator for Arcutis’ AD trial and a dermatology professor at the UC San Diego School of Medicine, said in a statement.
Pooled data from two Phase 3 studies reported in January showed a statistically significant number of patients treated with Zoryve notched at least a 50% improvement in AD symptoms compared to patients given a vehicle, as measured on a scale of AD severity. At the four-week mark, 69.2% of patients given Zoryve had 50% improvement, compared to 44.4% receiving a vehicle.
Nearly 10% of patients reported a 100% improvement in symptoms, compared to 4.8% of vehicle-treated trial participants.
Arcutis hopes the new indication will aid continued growth of the drug. Revenue has been a slow but steady climb, with Arcutis tallying $21.6 million in sales in the first quarter and nearly 4,500 total weekly prescriptions in the US as of the end of March. At the Goldman Sachs Annual Global Healthcare Conference in June, CEO Frank Watanabe said that the cream was starting to pick up Medicare and Medicaid coverage and a company spokesperson confirmed it’s now covered under Texas’ Medicaid program.
The approval in atopic dermatitis places Zoryve squarely in competition with Opzelura, Incyte’s JAK inhibitor cream that brought in $86 million in revenue in the first quarter of 2024. Both are looking to take a slice out of the pie from Sanofi and Regeneron’s Dupixent, which earned €10.7 billion ($11.5 billion) in 2023 across five indications, including moderate to severe atopic dermatitis in patients who don’t respond to topical treatments.
Arcutis is already aiming for Zoryve’s next approval and plans to ask the FDA for a label expansion of its foam formulation in the third quarter to treat scalp psoriasis.