FDA gave its nod to 55 new drugs in 2023

The past year was a return to form for approvals of new drugs by the US Food and Drug Administration. There were 55 new molecular entities that cleared the FDA’s hurdles in 2023. That number is up dramatically from the 37 the agency approved in 2022 and similar to the pace the agency set in years past, with 50 new approvals in 2021, 53 in 2020, 48 in 2019, and a record high of 59 in 2018. The 31 small-molecule therapies approved last year accounted for 56% of the new drugs, up from 46% in 2022. Antibodies were also plentiful among the 2023 approvals: the FDA approved 12 of them, making up 22%.

The FDA began 2023 with its accelerated approval of Eisai and Biogen’s Leqembi (lecanemab), an antibody treatment for Alzheimer’s disease. The drug received full approval in July, when the agency designated it as the first drug proven to slow the progression of Alzheimer’s.

Other noteworthy approvals include Melinta Therapeutics’ antifungal Rezzayo (rezafungin), which prevents yeast infections in the bloodstream, and full approval of Pfizer’s COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir), which doctors previously prescribed under emergency use authorization.

C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research, so it does not include blood products, gene therapies, vaccines, and other therapies that are approved by the FDA’s Center for Biologics Evaluation and Research. Notable approvals from that center include several vaccines to prevent respiratory syncytial virus. It also approved Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy and Bluebird Bio’s Lyfgenia, the first cell-based gene therapies the FDA approved for sickle cell disease. Casgevy is the first FDA-approved treatment to use CRISPR genome-editing technology.