UCB, a global biopharmaceutical company, received U.S. FDA approval for RYSTIGGO (rozanolixizumab-noli), for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

RYSTIGGO injection for subcutaneous infusion is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRN), resulting in the reduction of circulating IgG. It is the only FDA-approved treatment in adults for both anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.

The FDA approval is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study (NCT03971422). RYSTIGGO will be commercially available in the U.S. during the 3rd quarter of 2023.

“No two people living with gMG experience the disease in the same way, so we can’t take a ‘one size fits all’ approach to disease management,” said Iris Loew-Friedrich, executive vice-president, and chief medical officer at UCB. “Disease management should be based on the clinical needs and preferences of the individual patient, and the aim of treatment is to help restore that patient’s ability to carry out activities of daily living. The approval of RYSTIGGO means doctors have an additional approved treatment option for their gMG patients who have not yet found a treatment that meets their needs.”

The FDA reviewed RYSTIGGO under priority review. RYSTIGGO is also currently under review by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with gMG.