Rozanolixizumab: First Approval.

ABSTRACT: Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO^®) is a high affinity humanized immunoglobulin G4 monoclonal antibody directed against human neonatal Fc receptor (FcRn). Administered subcutaneously, it is being developed by UCB Pharma for the treatment of autoimmune diseases and received its first approval on 27 June 2023 in the USA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. Rozanolixizumab is the first agent to be approved in the USA for both anti-AChR and anti-MuSK antibody-positive gMG. A regulatory assessment of rozanolixizumab for the treatment of gMG is currently underway in the EU and Japan. Clinical development is ongoing for the treatment of leucine

SUBMITTER: Hoy SM 

PROVIDER: S-EPMC10590285 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature