PMID- 37656420
OWN - NLM
STAT- MEDLINE
DCOM- 20230921
LR  - 20231024
IS  - 1179-1950 (Electronic)
IS  - 0012-6667 (Print)
IS  - 0012-6667 (Linking)
VI  - 83
IP  - 14
DP  - 2023 Sep
TI  - Rozanolixizumab: First Approval.
PG  - 1341-1347
LID - 10.1007/s40265-023-01933-1 [doi]
AB  - Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO((R))) 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-rich 
      glioma-inactivated 1 autoimmune encephalitis, myelin oligodendrocyte glycoprotein 
      (MOG) antibody disease and severe fibromyalgia syndrome. This article summarizes 
      the milestones in the development of rozanolixizumab leading to this first 
      approval for the treatment of gMG in adults who are anti-AChR or anti-MuSK 
      antibody positive.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Hoy, Sheridan M
AU  - Hoy SM
AD  - Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. 
      dru@adis.com.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - New Zealand
TA  - Drugs
JT  - Drugs
JID - 7600076
RN  - P7186074QC (rozanolixizumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
EIN - Drugs. 2023 Nov;83(16):1569. PMID: 37861882
MH  - Adult
MH  - Infant, Newborn
MH  - Humans
MH  - Antibodies, Monoclonal, Humanized/pharmacology/therapeutic use
MH  - *Encephalitis
MH  - *Glioma
MH  - *Myasthenia Gravis/drug therapy
PMC - PMC10590285
COIS- During the peer review process the manufacturer of the agent under review was 
      offered an opportunity to comment on the article. Changes resulting from any 
      comments received were made by the authors on the basis of scientific 
      completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis 
      International Ltd/Springer Nature, and declares no relevant conflicts of 
      interest. All authors contributed to this article and are responsible for its 
      content.
EDAT- 2023/09/01 12:42
MHDA- 2023/09/21 06:42
PMCR- 2023/09/01
CRDT- 2023/09/01 11:17
PHST- 2023/09/21 06:42 [medline]
PHST- 2023/09/01 12:42 [pubmed]
PHST- 2023/09/01 11:17 [entrez]
PHST- 2023/09/01 00:00 [pmc-release]
AID - 10.1007/s40265-023-01933-1 [pii]
AID - 1933 [pii]
AID - 10.1007/s40265-023-01933-1 [doi]
PST - ppublish
SO  - Drugs. 2023 Sep;83(14):1341-1347. doi: 10.1007/s40265-023-01933-1.