Amgen Secures EC Approval for UPLIZNA Twice-Yearly Dosing in AChR+ and MuSK+ gMG
European Commission approved UPLIZNA as the first CD19-targeted therapy for anti-AChR+ and anti-MuSK+ myasthenia gravis, offering twice-yearly dosing after two loading doses. In Phase 3 MINT, UPLIZNA achieved a 1.9-point MG-ADL and 2.5-point QMG advantage at Week 26 and enabled 87.4% of patients to reduce steroids to ≤5 mg/day.
1. EC Approval for UPLIZNA
The European Commission has approved UPLIZNA (inebilizumab) as an add-on treatment to standard therapy for adults with anti-AChR+ and anti-MuSK+ generalized myasthenia gravis, marking the first CD19-targeted therapy authorized in Europe for this indication. The regimen includes two initial loading doses followed by twice-yearly maintenance dosing.
2. Key MINT Trial Outcomes
In the Phase 3 MINT trial of 238 adults (190 AChR+ and 48 MuSK+), UPLIZNA demonstrated a 1.9-point greater reduction in MG-ADL score and a 2.5-point improvement in QMG score versus placebo at Week 26 (both p<0.001). By Week 26, 87.4% of patients on UPLIZNA had tapered steroids to 5 mg or less per day.
3. Commercial and Market Impact
Generalized myasthenia gravis affects an estimated 56,000-123,000 people in Europe, offering a significant new market for UPLIZNA. This approval adds to UPLIZNA’s existing European indications in IgG4-related disease and neuromyelitis optica spectrum disorder, potentially expanding Amgen’s autoimmune franchise and revenue streams.