Arcutis Biotherapeutics (Arcutis) has announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the company’s 0.3% cream, Zoryve (roflumilast), for the treatment of plaque psoriasis.
The cream is approval for patients aged 12 years and over and can be applied to areas of skin-to-skin contact. The approval makes Arcutis’ treatment the first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for plaque psoriasis.
Topical treatments are still the primary treatment channel for most people living with the condition. This remains the case because of the unique treatment challenges presented by the disease, with its ability to affect any part of the body. Subsequently, patients are then prescribed multiple topical medications for different areas, resulting in a complicated treatment regimen.
As a once-daily, steroid-free cream, Zoryve has been shown to provide a rapid clearance of psoriasis plaques and a significant reduction in itch in all affected areas of the body, offering people living with the condition a simplified option for disease management. Moreover, the cream can be used in mild, moderate and severe cases of plaque psoriasis, with no indicated limitations for use.
Frank Watanabe, president and chief executive officer of Arcutis, said: “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.”
Arcutis plans to make Zoryve widely available via key wholesaler and national dermatology pharmacy channels by mid-August this year, the company said.
The Zoryve Direct patient support programme will help commercially insured individuals with plaque psoriasis gain access and begin Zoryve treatment as prescribed by their healthcare provider, therefore reducing the cost for eligible patients, and offering programmes that support staying on therapy.
Alongside this, Arcutis will also offer the Arcutis Cares patient assistance programme (PAP) as a first-of-its-kind for a topical psoriasis treatment, that will offer Zoryve at no cost for financially eligible patients who are uninsured or underinsured.