Arcutis Biotherapeutics: FDA To Review SNDA For Roflumilast Cream 0.15%

(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT) announced the FDA has accepted its supplemental new drug application for roflumilast cream 0.15% for the treatment of atopic dermatitis in adults and children down to age 6. The FDA assigned the application a PDUFA target action date of July 07, 2024.

The company said its sNDA is supported by positive results from three Phase 3 programs as well as a Phase 2 dose ranging study, and two Phase 1 pharmacokinetic studies. Roflumilast cream is a next generation topical PDE4 inhibitor.

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