• The FDA has approved Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis (gMG) in adults with specific antibody-positive subtypes.
• Rystiggo, a humanized IgG4 monoclonal antibody, reduces circulating IgG levels by binding to the neonatal Fc receptor (FcRN).
• Clinical trials demonstrated statistically significant improvements in MG-ADL and QMG scores with Rystiggo compared to placebo.
• The most common adverse reactions reported were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.