Shots:
- FDA approved Zoryve (0.05% roflumilast; QD) for pts (2-5yrs.) based on P-III (INTEGUMENT-PED), INTEGUMENT-OLE study & a P-I PK trial; commercially available by end of Oct 2025
- INTEGUMENT-PED (n=652) showed rapid disease clearance with benefits from Wk. 1, as 25.4% vs 10.7% achieved vIGA-AD Success & a 2-grade improvement at Wk. 4; trial also met all 2EPs. 39.4% vs 20% achieved EASI-75 & ~33.3% vs 18% with baseline WI-NRS score ≥4 reached ≥4-point itch reduction by Wk. 4
- In INTEGUMENT-OLE (n=1,220), pts were treated up to 56wks., with 71.9% achieving EASI-75. From Wk. 4, 170 pts, who achieved vIGA-AD (0) switched to twice-weekly dosing & had disease control for a median duration of 34wks.
Ref: Arcutis Biotherapeutics| Image: Arcutis Biotherapeutics| Press Release
Related News:- The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis
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