FDA Approves Zoryve for Children with Plaque Psoriasis

FDA has approved the supplemental new drug application (sNDA) for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis in children 6 to 11 years of age. Developed by Arcutis Biotherapeutics, Zoryve is a once-daily, steroid-free cream. This approval expands Zoryve indications; it was approved in July 2022 to treat those 12 years and older for the same indication.

The dosage for children 6 to 11 is the same as for those over the age of 12 and pricing is same for both pediatrics and adults, according to an Arcutis spokesperson.

Zoryve’s wholesale acquisition cost is $825 per tube. Those with commercial drug insurance may be eligible for the Zoryve Direct Savings Card. Patients may pay as little as $25 if their commercial drug insurance covers Zoryve, and $75 if their commercial drug insurance currently does not. Individual patient savings are limited to $875 per fill and $5,000 in maximum total savings per calendar year.

As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 6 to 11 years of age, and presents with very similar clinical features, including “plaques,” or raised, red areas of skin covered with a silver or white layer of dead skin cells.

Adelaide A. Hebert, M.D.,

“In children, psoriasis ranges from mild to severe, and more often appears on sensitive areas including the face and skin folds, compared with adults. Topical steroids are commonly recommended medications for the treatment of pediatric psoriasis. However, they come with safety and tolerability concerns related to long-term use. Steroid-free topical treatments that can be used on sensitive areas are especially needed for managing plaque psoriasis in younger children,” Adelaide A. Hebert, M.D., professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann, said in a press release.

The additional approval is based on data from a four-week study Maximal Usage Systemic Exposure (MUSE) in children 6 to 11 years of age with plaque psoriasis. Pharmacokinetic, safety, tolerability, and efficacy data from this study were generally consistent with data from the DERMIS-1 and DERMIS-2 pivotal phase 3 trials in adults. The use Zoryve is children 2 to 5 years of age is being evaluated in second MUSE study, and an open label extension study is ongoing to assess the long-term safety of roflumilast cream.