Arcutis Biotherapeutics announced the commercial launch of ZORYVE® (roflumilast) cream 0.15% for the treatment of mild-to-moderate atopic dermatitis in adults and children down to age 6 in the United States, along with a co-promotion agreement with Kowa Pharmaceuticals America, Inc. ZORYVE is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch, and was developed to provide long-term disease control.

"Atopic dermatitis is a complex disease that affects tens of millions of adults and children in the United States. While topical therapies are often prescribed to treat this chronic disease, they come with limitations on duration of use or side effects that require careful management. ZORYVE is a once-daily cream developed with the atopic dermatitis patient in mind, that can effectively and safely be used to relieve symptoms anywhere on the body,” said Todd Edwards, chief commercial officer at Arcutis.

ZORYVE cream 0.15% will be available in pharmacies this week. ZORYVE cream is listed as a line extension within two commercial PBM contracts, providing immediate insurance coverage for many patients.

“The yet-to-be-satisfied goal for atopic dermatitis treatment is the establishment of long-term disease control by a therapy that is well tolerated by patients and also effective in both reducing inflammation as well as the most burdensome symptom in atopic dermatitis—itch. The unique formulation of ZORYVE cream helps to deliver the active ingredient while avoiding excipients that commonly cause skin barrier disruption, irritation, or contact allergy, which makes it well-suited for long-term continuous use in the treatment of this chronic inflammatory condition," said Rocco Serrao, MD, FAAD.

Meanwhile, Kowa will leverage its primary care sales force to market and promote ZORYVE cream and ZORYVE foam to primary care practitioners and pediatricians for all FDA-approved indications. Arcutis will maintain responsibility for the marketing and sales of ZORYVE to dermatologists, other dermatology clinicians, and related specialists. This partnership is expected to expand the total addressable market for ZORYVE, providing access to a large portion of the 7.4 million patients treated outside of dermatology offices.