Highlights
– The FDA approved inebilizumab-cdon (Uplizna), a CD19-targeted B-cell depleting monoclonal antibody, for adults with generalized myasthenia gravis (gMG) who are positive for anti‑AChR or anti‑MuSK antibodies.
– Approval was supported by the phase 3 randomized, placebo-controlled MINT trial (n = 238), which met the primary efficacy endpoint: a 1.9‑point difference in Myasthenia Gravis Activities of Daily Living (MG‑ADL) score at week 26 (−4.2 vs −2.2; P < .0001).
