Arcutis submits sNDA for Zoryve foam 0.3% for scalp, body psoriasis
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Key takeaways:
- The submission is for the treatment of adults and adolescents aged 12 years and older with scalp and body psoriasis.
- The submission is supported by a phase 3 trial, a phase 2b trial and long-term data.
Arcutis has submitted a supplemental new drug application for Zoryve foam 0.3% for the treatment of scalp and body psoriasis in adults and adolescents aged 12 years and older, according to a company press release.
Zoryve (roflumilast) foam 0.3%, a once-daily, steroid-free topical, is currently approved for the treatment of seborrheic dermatitis and its cream formulation is approved for plaque psoriasis in adult and pediatric populations aged 9 years and older and 6 years and older, respectively. Zoryve cream 0.15% was also recently approved for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients aged 6 years and older.
“This important milestone represents our fifth topical roflumilast regulatory submission in the United States in less than 3 years and brings another innovative treatment to the large population of individuals with scalp and body psoriasis,” Frank Watanabe, president and CEO of Arcutis, said in the release. “Based on the rapid adoption of Zoryve foam in seborrheic dermatitis due to the simplicity of using one treatment anywhere on the body, including hair-bearing areas, we believe there is great potential for its adoption in scalp and body psoriasis, once approved.”
The submission is supported by results from the phase 3 ARRECTOR trial, a phase 2b study and long-term data from the company’s development program for Zoryve cream in plaque psoriasis.
In the ARRECTOR trial, 67.3% of individuals treated with Zoryve foam 0.3% achieved scalp IGA scores of clear or almost clear plus a 2-point improvement from baseline, whereas only 28.1% of individuals in the vehicle group achieved the same by week 8. Similarly, 46.5% of those treated with Zoryve achieved body IGA scores of clear or almost clear vs. 20.8% of vehicle-treated patients by week 8.
According to the release, Zoryve was well tolerated with a low incidence of treatment-emergent adverse events that were mainly mild to moderate in severity.