UPLIZNA Gets FDA Nod for Generalized Myasthenia Gravis: What This Means for Amgen's Pipeline

probably_nothing_anon · 2025-12-26T01:07:10+00:00

Amgen's UPLIZNA received FDA approval for generalized myasthenia gravis in adults with specific antibodies, covering about 85% of cases. The approval is based on positive Phase 3 trial results, positioning UPLIZNA as a unique therapy with strong market potential.

probably_nothing_anon

2025-12-26 01:07:10

Abstract generation in progress

Amgen just scored another major win with UPLIZNA—the company revealed that FDA approval has been expanded to cover generalized myasthenia gravis (gMG) in adults testing positive for anti-AChR or anti-MuSK antibodies. This is a big deal because gMG represents about 85% of all myasthenia gravis cases (the other form being ocular myasthenia gravis, which is less severe).

The Clinical Evidence Behind the Approval

The FDA’s decision hinged on Phase 3 MINT trial results, where UPLIZNA demonstrated solid performance in both antibody-positive populations. Patients with anti-acetylcholine receptor (AChR+) antibodies showed improvement at 26 weeks and continued progressing through the 52-week mark. Anti-muscle-specific tyrosine kinase (MuSK+) patients similarly responded well. Worth noting: roughly 85% of gMG patients carry AChR antibodies, while about 7% have MuSK antibodies—so this approval covers the vast majority of the antibody-positive gMG population.

Competitive Positioning and Market Impact

What makes this interesting is that UPLIZNA is now the only CD19-targeted B-cell therapy approved for anti-AChR and anti-MuSK antibody-positive gMG. It’s Amgen’s third approved indication, joining existing approvals for neuromyelitis optica spectrum disorder (NMOSD) and IgG4-related disease (IgG4-RD).

The sales trajectory tells part of the story: UPLIZNA generated $379 million in full-year 2024 sales and hit $422 million in just the first nine months of 2025. That acceleration suggests the market is warming to this mechanism of action.

AMGN closed trading on Thursday at $317.38, up 0.63%, reflecting measured investor confidence in the pipeline expansion.

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