The US Food and Drug Administration approved new drugs at a substantial clip last year, even as the agency continued to maneuver through other urgent business related to the continuing COVID-19 pandemic, including evaluating tests, vaccines for children, and antiviral compounds. The agency approved 50 new molecular entities in 2021, just three fewer than the number it cleared in 2020.
Among the new approvals were 31 small molecules, accounting for 62% of the new drug pipeline. Notable new small-molecule drugs include a long-acting HIV therapy, a novel antifungal, and an inhibitor of KRAS G12C—a cancer target that drugmakers have been pursuing for years.
Larger molecular entities also had a strong year, with several antibodies and protein therapeutics getting the FDA’s nod. The agency also approved two anticancer antibody-drug conjugates, a cholesterol-lowering drug that works through RNA interference, and a controversial antibody treatment for Alzheimer’s disease.
By the numbers
New molecular entities approved in 2021
Small-molecule drugs approved
Antibody or antibody fragment drugs approved
Protein drugs approved
Antibody-drug conjugates approved
Source: The US Food and Drug Administration.