The USFDA has approved rozanolixizumab for treating generalized myasthenia gravis (gMG) in adults positive for the anti-acetylcholine receptor or the anti-muscle-specific tyrosine kinase antibody . Rozanolixizumab is the only FDA-approved treatment in adults with the two subtypes of gMG. It is a humanized IgG4 monoclonal antibody that generally binds to the neonatal Fc receptors. The approval is supported by safety and efficacy data from the phase 3 MycarinG study.
Data from the phase 3 MycarinG trial 200 adult patients were randomized 1:1:1 to receive either a placebo or one of the two weight-based doses of rozanolixizumab (≈7 mg/kg or ≈10 mg/kg). Rozanolixizumab improved the symptoms of gMG in patients, which was reflected in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score compared to placebo (-3.4 [in both ≈7 mg/kg and ≈10 mg/kg groups] vs. -0.8). Dosage and…
