Overview
- Authorization covers adults with antibody‑positive disease limited to AChR‑ or MuSK‑positive generalized myasthenia gravis.
- Uplinza becomes the medicine’s third U.S. indication and introduces a regimen of two loading doses followed by two maintenance doses each year.
- Approval is backed by the Phase 3 MINT trial, which measured outcomes through Week 26.
- At Week 26, patients on Uplinza achieved a 1.9‑point greater improvement in MG‑ADL versus placebo (−4.2 vs. −2.2).
- In steroid‑tapering analyses, 87.4% on Uplinza and 84.6% on placebo reduced prednisone to 5 mg/day or less by Week 26, and Amgen shares rose about 0.3% intraday after the news.