Structure and function of therapeutic antibodies approved by the US FDA in 2023

Abstract

In calendar year 2023, the United States Food and Drug Administration (US FDA) approved a total of 55 new molecular entities, of which 12 were in the class of therapeutic antibodies. Besides antibody protein drugs, the US FDA also approved another five non-antibody protein drugs, making the broader class of protein drugs about 31% of the total approved drugs. Among the 12 therapeutic antibodies approved by the US FDA, 8 were relatively standard IgG formats, 3 were bivalent, bispecific antibodies and 1 was a trivalent, bispecific antibody. In 2023, no new antibody-drug conjugates, immunocytokines or chimeric antigen receptor-T cells were approved. Of the approved antibodies, two targeted programmed cell death receptor-1 (PD-1) for orphan indications, two targeted CD20 for diffuse large B cell lymphoma, two targeted different receptors (B-cell maturation antigen [BCMA] and G-coupled protein receptor class C, group 5, member D [GPRC5D]) for treatment of multiple myeloma, and one each that targeted amyloid-β protofibrils for Alzheimer's disease, neonatal Fc receptor alpha-chain for myasthenia gravis, complement factor C5 for CD55 deficiency with hyper-activation of complement, angiopathic thrombosis and severe protein-losing enteropathy disease, interleukin (IL)-23p19 for severely active ulcerative colitis, IL-17A-F for plaque psoriasis and respiratory syncytial virus (RSV)-F protein for season-long RSV prophylaxis in infants.

Keywords: US FDA; bispecific antibodies; new molecular entities; therapeutic antibodies.