Shots:
- FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks.
- ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining Body-IGA success at Wk. 8; Trial 204 also met its 1EP of S-IGA (56.7% vs 11%) & showed 39.0% vs 7.4% pts reaching B-IGA success at Wk. 8
- In ARRECTOR, 65.3% vs 30.3% achieved a ≥4-point scalp itch reduction on SI-NRS at Wk. 8, with improvement seen in 24hrs. after 1st use; Trial 204 showed similar results (67.3% vs 20.7%). Zoryve also improved body itch, with 63.1% vs 30.1% achieving ≥4-point WI-NRS reduction at Wk. 8
Ref: Arcutis Biotherapeutics| Image: Arcutis Biotherapeutics| Press Release
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