Shots:
- The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriate
- Approval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75 & IGA‑TS, plus approval was further supported by the P-III (TRuE-AD1) & P-III (TRuE-AD2) studies
- Trial showed 84.3% pts achieved EASI75 & 70.6% reached IGA-TS at Wk. 24, while itch relief remained high (74.3% at Wk. 8 & 64.7% at Wk. 24 had ≥4-point improvement in Itch NRS). Pts showed improved QoL, with DLQI scores improving from 19.3 to 4.3 at Wk. 8 (vs 19.1 to 10.7 with vehicle)
Ref: Businesswire | Image: Incyte | Press Release
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