Arcutis Receives the US FDA Approval for Zoryve (roflumilast) to Treat Seborrheic Dermatitis in Individuals Aged 9 Years and Older
Shots:
- The approval was supported by P-II (Trial 203) & P-III (STRATUM) study evaluating the safety & efficacy of Zoryve foam, 0.3% vs Vehicle in patients (n=683) with seborrheic dermatitis
- The P-III (STRATUM) study met its 1EP that showed IGA success rate in nearly 80% of individuals vs 58% by 8 wks. Additionally, significant improvements were observed in all 2EPs, incl. itch, scaling, & erythema. More than 60% of individuals experienced a ≥4-point reduction in itch by Week 8
- In addition, more than 50% of individuals achieved an erythema score of 0, & more than 50% achieved a scaling score of 0 at 8wks. In P-II (Trial 203), Zoryve foam exhibited IGA Success rate in 73% of individuals vs 40.8%
Ref: Arcutis | Image: Arcutis
Related News:- Arcutis’ Zoryve (roflumilast) Receives the US FDA's NDA Approval for Plaque Psoriasis in Individuals Aged ≥12 Years
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
