Shots:
- The approval is based on 3 P-III studies i.e., Measure Up 1/2/AD Up evaluating the efficacy & safety of Rinvoq (15/30 mg, qd) as monothx. with TCS vs PBO in 2500+ adults & adolescents with AD
- The studies met its 1EPs & 2EPs @16wks. i.e., improvement in skin clearance & itch reduction, patients achieved EASI 75 (70%/ 60%/65%) & (80%/ 73%/ 77%) vs (16%/13%/26%); vIGA-AD 0/1 (48%/39%/31%) & (62%/ 52%/ 59%) vs (8%/5%/11%), improvement in Worst Pruritus NRS ≥4 (52%/ 42%/ 52%) & (60%/ 60%/ 64%) vs (12%/ 9%/ 15%). The results continued to be maintained for 52wks.
- The approval marks the 4th indication in the EU with previous approval in RA, PsA & AS and is approved in the US for RA
Click here to read full press release/ article | Ref: Abbvie | Image: Pharma Live
The post AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval for the Treatment of Moderate to Severe Atopic Dermatitis first appeared on PharmaShots.
