Monday, July 15, 2024

Atopic Dermatitis Breakthrough: FDA Approves Arcutis’s Zoryve for Atopic Dermatitis

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Atopic dermatitis (AD), a prevalent form of eczema, has seen a new treatment approval with Arcutis Biotherapeutics successfully securing the U.S. Food and Drug Administration (FDA) approval for Zoryve (roflumilast) after several days of investor anxiety. The FDA decision, initially expected on July 7th, was delayed, causing concern among shareholders. In response, Arcutis issued a statement reassuring investors that no additional information had been requested by the FDA and that they anticipated receiving the approval letter soon.

Later that day, Arcutis confirmed that Zoryve had been approved as a once-daily treatment for mild to moderate atopic dermatitis in adults and children aged six and older. This new indication adds to Zoryve’s previous approvals for plaque psoriasis and seborrheic dermatitis, a form of eczema primarily affecting the scalp. The reasons behind the FDA’s delay remain undisclosed.

Zoryve Approved for Atopic Dermatitis: Phase 3 Trials Show 91.5% Improvement in EASI

Zoryve, a topical phosphodiesterase 4 inhibitor, was approved based on phase 3 clinical trial data demonstrating its efficacy. The trials showed that 91.5% of patients treated for atopic dermatitis experienced significant improvement in the Eczema Area and Severity Index (EASI) after four weeks. Zoryve provides a versatile treatment option as it can be applied anywhere on the body, unlike corticosteroids, which are not recommended for use on the face and carry risks of skin thinning with prolonged use.

The phase 3 INTEGUMENT program also highlighted Zoryve’s effectiveness in reducing itch, the most troublesome symptom of atopic dermatitis. Results indicated that 69% of patients achieved a clinically meaningful reduction in itch after four weeks, with some experiencing relief within 24 hours. Lawrence Eichenfield from the UC San Diego School of Medicine, an investigator in the INTEGUMENT study, emphasized the significance of having a new, effective, steroid-free option that mitigates the risks associated with topical and systemic steroids.

Atopic Dermatitis

Zoryve Approval for Atopic Dermatitis Expected to Boost Sales Momentum in Expanding Market

The approval of Zoryve for atopic dermatitis is expected to drive additional sales momentum. The medication is available in a 0.3% cream for psoriasis and a 0.3% topical foam for seborrheic dermatitis. In the first quarter of this year, these formulations generated approximately $22 million, an increase from the $60 million recorded last year. Atopic dermatitis is a far more common condition, affecting 9.6 million children and 16.5 million adults in the US alone, indicating a significant market potential for Zoryve.

Despite the promising outlook, Zoryve faces competition from other non-steroid treatments. Incyte’s JAK inhibitor Opzelura (ruxolitinib), approved for atopic dermatitis in 2021, requires twice-daily dosing and has a more restrictive label for short-term and non-continuous chronic treatment in adults and children aged 12 and over. Opzelura generated sales of just over $100 million last year from its use in atopic dermatitis and vitiligo.

Other potential competitors include Dermavant’s Vtama (tapinarof), which is already approved for psoriasis and awaiting an FDA decision for atopic dermatitis in patients aged two and older later this year, and Leo Pharma’s JAK inhibitor delgocitinib, approved in Japan for atopic dermatitis and filed for approval in chronic hand eczema in the US and Europe.

In summary, the FDA’s approval of Zoryve as a treatment for atopic dermatitis marks a significant milestone for Arcutis Biotherapeutics, offering a new, steroid-free option for managing this common and often debilitating condition. With its demonstrated efficacy and favorable safety profile, Zoryve is poised to make a substantial impact on the treatment landscape for atopic dermatitis, benefiting millions of patients and potentially driving significant revenue growth for Arcutis. The approval also underscores the ongoing advancements in dermatological therapies, providing hope for improved management of various skin conditions.

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Resource: Arcutis, July 10, 2024

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