Shots:
- Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25
- Pts received an initial loading dose of Uplizna followed by 2 doses per year, while pts on corticosteroids began tapering at Wk. 4, reducing to prednisone (5 mg/day) by Wk. 24. Eligible pts could also opt for 3yr. OLE study
- Trial showed durable efficacy in AChR+ pts, with 72.3% vs 45.2% achieving ≥3-point MG-ADL improvement & 69.2% vs 41.8% showing ≥3-point QMG improvement by 52wks; data to be presented at AAN 2025
Ref: Amgen | Image: Amgen
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