Novel targeted drugs approved by the NMPA and FDA in 2019
Wenjing Wang, Qiu Sun
Abstract
In 2019, the FDA’s Center for Drug Evaluation and Research (CDER) approved 48 novel drugs [ https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019 ], 1 which was fewer than the all-time record of 62 NTD approvals in 2018, 2 but it was still a fruitful year. Among these approved drugs, 39 were targeted drugs (Table 1 ), including 27 small molecules, 3 antibody-drug conjugates (ADCs), 1 RNA interference (RNAi) therapy, 1 antisense oligonucleotide, 4 monoclonal antibodies (mAbs), 1 recombinant fusion protein, and 2 synthetic peptide analogs. The targets included kinases, ion channels, exons, enzymes, and receptors. Oncology, which remains the most important drug discovery area, accounted for 23% (9/39) of the targeted drug approvals. Table 1 Targeted drugs approved by the FDA in 2019 Full size table