Arcutis Reports the sNDA Submission of Zoryve Foam to the US FDA for Treating Scalp and Body Psoriasis
Shots:
- The sNDA submission was based on development programs incl. P-IIb & P-III (ARRECTOR) assessing the safety & efficacy of Zoryve (roflumilast) foam 0.3% (QD) vs matching vehicle for treating scalp & body plaque psoriasis among adults & adolescents (n=432; age: ≥12yrs.)
- Study reached the co-1EPs, showing Scalp-Investigator Global Assessment (S-IGA) success in 67.3% vs 28.1%, Body-Investigator Global Assessment (B-IGA) success in 46.5% vs 20.8% and itch reduction in 65.3% vs 30.3% after wk.8
- Furthermore, patients experienced relief from scalp itch within 24hrs. of the first foam application. At wk.8, 63.1% vs 30.1% had a ≥4-point reduction in body itch (WI-NRS) with improvements, also noted at wk.2
Ref: Arcutis | Image: Arcutis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
