Arcutis Gets FDA Nod For Plaque Psoriasis Candidate, Sees Commercial Launch In Mid-August

The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ ARQT New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in patients 12 years of age or older.

The regulatory approval is based on comprehensive results from the pivotal DERMIS-1 and DERMIS-2 (trials of PDE4 inhibition with Roflumilast for the Management of plaque psoriasIS One and Two) Phase 3 studies.

In both DERMIS-1 and DERMIS-2 trials, ZORYVE was very well-tolerated with a favorable safety and tolerability profile.

ZORYVE provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body.

Frank Watanabe, President and CEO, commented: "Today Arcutis has reached a major milestone, with our ability to offer this next generation topical PDE4 inhibitor to both adults and adolescents with plaque psoriasis. ZORYVE's combination of efficacy, safety, and tolerability, coupled with our proprietary HydroARQ Technology formulation, is designed to fit into patients' everyday lives with no restrictions on duration of use.”

The company is planning to make ZORYVE widely available via key wholesaler and national dermatology pharmacy channels as a new treatment option by mid-August.

Price Action : Arcutis shares closed Friday’s trading 4 percent higher at $24.26