Sunday, February 9, 2025

Arcutis Biotherapeutics Secures FDA Approval for ZORYVE in Seborrheic Dermatitis Treatment

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Arcutis Biotherapeutics has obtained FDA approval for ZORYVE (roflumilast) topical foam, 0.3%, intended to address seborrheic dermatitis in individuals aged nine and above. This approval signifies a substantial advancement in treatment options for this condition, particularly given the last approved drug for this purpose emerged over two decades ago.

In clinical trials, ZORYVE foam demonstrated notable efficacy, with almost 80% of individuals achieving the primary efficacy endpoint of IGA Success, while over 50% experienced complete clearance by Week 8 in the STRATUM trial. Offering rapid disease clearance and a significant reduction in itch, ZORYVE represents a pioneering topical treatment with a novel mechanism of action.

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Dr. Patrick Burnett, Arcutis’ chief medical officer, highlighted the challenges faced by both dermatologists and individuals coping with seborrheic dermatitis. These challenges encompassed issues related to treatment adherence, efficacy limitations, and concerns regarding prolonged usage of existing therapies. ZORYVE’s introduction as a steroid-free foam enables its application across the body, including hair-covered areas, without duration restrictions, thereby simplifying the management of this dermatological condition.

Seborrheic Dermatitis

Pioneering Efficacy in Seborrheic Dermatitis Treatment

Seborrheic dermatitis, characterized by red patches covered with flaky scales and persistent itching, affects more than ten million individuals in the US. Primarily occurring in regions with oil-producing glands like the scalp, face, upper chest, and back, treating these areas often poses challenges when using traditional topicals such as creams, gels, or ointments.

Arcutis aims to make ZORYVE foam widely accessible through major wholesaler and dermatology pharmacy channels by the end of January next year, catering to the millions of adults and adolescents grappling with seborrheic dermatitis. This approval marks a significant step in addressing the unmet needs of individuals dealing with this chronic skin condition.

 

Resource: Pharmaceutical Business Review, December 18, 2023


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