Roflumilast Cream 0.15% Launched by Arcutis for the Treatment of Eczema

Rocco Serrao MD, FAAD

Credit: DOCS Dermatology

Biopharmaceutical company Arcutis Biotherapeutics, Inc., announced the launch of roflumilast cream (Zoryve) 0.15% for treating mild to moderate atopic dermatitis in adults and children aged 6 years and above with mild-to-moderate disease.¹

The announcement of the steroid-free, once-daily cream’s launch follows the drug’s approval by the US Food and Drug Administration (FDA) in early July.² The medication was formulated to allow for rapid disease clearance and substantial reductions in pruritus, leading to longer-term disease control.

“The yet-to-be-satisfied goal for atopic dermatitis treatment is the establishment of long-term disease control by a therapy that is well tolerated by patients and also effective in both reducing inflammation as well as the most burdensome symptom in atopic dermatitis – itch,” Rocco Serrao MD, FAAD, said in a statement. “The unique formulation of (roflumilast) cream helps to deliver the active ingredient while avoiding excipients that commonly cause skin barrier disruption, irritation, or contact allergy, which makes it well-suited for long-term continuous use in the treatment of this chronic inflammatory condition.”

Atopic dermatitis, also known as eczema, is known to impact around 16.5 million adults in the US as well as 9.6 million children. The chronic, relapsing inflammatory skin disorder can appear as an itchy, red rash and shows some variation based upon geography and environment.

Roflumilast cream functions as a steroid-free, topical phosphodiesterase 4 (PDE4) inhibitor. It was also previously given FDA approval for seborrheic dermatitis as well as plaque psoriasis. PDE4 can raise pro-inflammatory mediators and decrease anti-inflammatory mediators.

The topical cream 0.15% was given an approval for patients aged 6 years and older with mild to moderate eczema, though roflumilast cream 0.3% was approved for psoriasis in the same age group. Roflumilast foam 0.3% was made available for those with seborrheic dermatitis in the age range of 9 years and older.

Beginning the week of July 29, roflumilast cream 0.15% is set to be made available within pharmacies and is included in two commercial PBM contracts. This will allow for immediate insurance coverage for many different patients.

The announcement by Arcutis emphasizes responsible pricing and the need for affordable access to their treatments, with a streamlined copay offered. They also noted that the topical cream is being assessed at a lower 0.05% dose for children aged 2 - 5 years with eczema.

Additionally, the company has submitted a supplemental new drug application for roflumilast foam 0.3% to treat individuals with scalp and body psoriasis.

References

1. ^{Arcutis Launches ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis. Arcutis Biotherapeutics. July 29, 2024. https://www.arcutis.com/arcutis-launches-zoryve-roflumilast-cream-0-15-for-the-treatment-of-atopic-dermatitis/. Date accessed: July 29, 2024.}
2. ^{Smith T, Campbell P. Arcutis Offers Update on Application for Roflumilast Cream 0.15% with FDA. HCPLive. July 9, 2024. https://www.hcplive.com/view/arcutis-offers-update-on-application-for-roflumilast-cream-0-15-with-fda. Date accessed: July 29, 2024.}