FDA approves Zoryve cream 0.3% for the treatment of plaque psoriasis.- Arcutis Biotherapeutics, Inc.
Arcutis Biotherapeutics, Inc., an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced that the FDA has approved the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older.
The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, Zoryve provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body. Zoryve — a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation — is uniquely formulated to simplify disease management for people living with plaque psoriasis.
While the disease may affect any area of the body, plaques in certain areas, like the face, elbows and knees, genitalia, and intertriginous areas (areas of skin-to-skin contact), present unique treatment challenges. As a result, individuals with psoriasis are often prescribed multiple topical medications for different areas, which makes for a complicated treatment regimen.
Zoryve features HydroARQ Technology, a proprietary drug delivery formulation that creates a non-greasy moisturizing cream that spreads easily and absorbs quickly.
Arcutis intends to make Zoryve widely available via key wholesaler and national dermatology pharmacy channels as a new treatment option by mid-August, and the company is dedicated to affordable access to therapy. The Zoryve Direct patient support program will help commercially insured individuals with plaque psoriasis get access and start Zoryve treatment as prescribed by their healthcare provider quickly and easily by helping them navigate the payer process, lowering the out-of-pocket cost for eligible patients, and offering programs that support staying on therapy.