By SPC News Staff
The FDA approved rozanolixizumab-noli (Rystiggo, UCB) to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR)- or anti–muscle-specific tyrosine kinase (MuSK) antibody–positive.
The approval was based on data from the MycarinG study, a multicenter, phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of rozanolixizumab-noli in adult patients with gMG, with an open-label extension