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On Tuesday, the FDA approved Arcutis Biotherapeutics Inc’s ARQT supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for mild to moderate atopic dermatitis in patients six years of age and older . “Today marks the third FDA approval of a commercial product for Arcutis in just the last two years, and we are thrilled to be able to offer ZORYVE cream 0.
15% as a new steroid-free treatment option to children and adults living with AD,” said Frank Watanabe, president and CEO of Arcutis. Arcutis intends to make Zoryve cream 0.15% widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July.
In the first quarter of 2024, the Zoryve franchise generated sales of $21.6 million, with $15 million for Zoryve cream, 0.3%, and $6.
5 million for Zoryve topical foam, 0.3%; sales growth was 675% year over year and 59% sequentially . Results from three Phase 3 studies, a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies support the sNDA.
INTEGUMENT-1 and INTEGUMENT-2 phase 3 trials met their primary endpoint of IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear plus a 2-grade improvement from baseline. Individuals treated with Zoryve cream experienced rapid and significant improvement in itch within 24 hours of the first application. In addition, over 40% of children and adults treated with Zor.