Abstract
In 2024, the Food and Drug Administration approved 47 new molecular entities (NMEs), including 15 therapeutic antibody-based molecules, marking the 30th anniversary of the first approved recombinant antibody. Ten of these were recombinant immunoglobulin G antibodies, while the rest comprised three bispecific antibodies, one immunocytokine, and one Fc-fusion protein. Seven antibodies targeted previously approved targets like programmed cell death receptor-1, programmed cell death receptor ligand-1, complement factor C5, interleukin (IL)-13, human epidermal growth factor receptor 2 (HER2) (biparatopic), and a novel form of amyloid-beta for conditions like esophageal squamous cell carcinoma, cutaneous squamous cell carcinoma, paroxysmal nocturnal hemoglobinuria, atopic dermatitis, biliary tract cancer, and Alzheimer's disease, respectively. The other seven recognized novel targets such as activin for pulmonary arterial hypertension, IL-15Rβγ agonist for bladder cancer, delta-like ligand-3 × cluster of differentiation-3 for small cell lung cancer (SCLC), IL-31 receptor for prurigo nodularis, colony stimulating factor-1 receptor for graft-versus-host disease, tissue factor pathway inhibitor for Hemophilia A and B, and claudin 18.2 for gastric or gastroesophageal junction cancers. Additionally, a HER2-HER3 bispecific antibody was approved for non-SCLC and pancreatic adenocarcinoma. Three reformulated antibodies with hyaluronidase HP20 for subcutaneous administration were also approved, although not as New Molecular Entities (NME)s.