Rystiggo Now Commercially Available for the Treatment of AChR or MuSK Antibody-Positive Generalized Myasthenia Gravis

Rystiggo (rozanolixizumab-noli; UCB, Atlanta, GA) is now commercially available in the United States by prescription for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti­–muscle-specific tyrosine kinase (MuSK) antibody positive. The Food and Drug Administration (FDA) approved Rystiggo in June 2023 under the Priority Review program based on safety and efficacy data from the pivotal phase 3 MycarinG clinical trial (NCT03971422).

The primary efficacy endpoint in the MycarinG clinical trial was met, with Rystiggo-treated participants showing greater reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores from baseline to day 43 compared with placebo-treated participants. The secondary endpoint, change in quantitative myasthenia gravis (QMG) score from baseline to day 43, also was met. The most commonly reported adverse reactions were headache, diarrhea, infections, pyrexia, nausea, and hypersensitivity reactions.

“For many people, myasthenia gravis is a chronic illness that continues to be overwhelming to patients due to function loss and inadequate control of symptoms,” said Samantha Masterson, CEO and President of the Myasthenia Gravis Foundation of America. "An additional FDA-approved targeted treatment that is now available provides a new option to eligible patients and their treating physicians who have not yet found an option that works for their needs."

Rystiggo, a humanized IgG4 monoclonal antibody targeting the neonatal Fc receptor (FcRN), is currently the only FDA-approved treatment for the MuSK- or AChR-antibody positive subtypes of gMG. Rystiggo is administered as a subcutaneous injection through a specialty distribution network or by infusion. UCB’s ONWARD program was established to assist in patient access for Rystiggo.