USA – FDA approved more first-in-class drugs, gave more accelerated approvals in 2021

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020, more drugs were designated as first-in-class and used the accelerated approval pathway than in previous years.

The approvals reported by CDER do not include biologics license applications (BLAs) approved by FDA’s Center for Biologics Evaluation and Research (CBER). In 2021, CBER approved 10 different biological products, including the COVID-19 vaccine Comirnaty, for a total of 60 novel therapeutics approvals.

“Throughout 2021, the COVID-19 pandemic continued to present significant challenges to our entire staff. In spite of these hardships, we have approved many therapies that will advance health for the American public,” CDER director Patrizia Cavazzoni, MD, wrote in the center’s recent annual report.

Of the 50 drugs approved by CDER in 2021, 38 drugs (76%) were approved first in the United States, the FDA said in the report. First-in-class drugs comprised 27 of 50 drugs (54%) approved in 2021 compared with 21 of 53 first-in-class drugs (39.6%) in 2020, the agency noted. This represents an upward trend in first-in-class drug approvals, as FDA had previously reported 20 drug approvals (42%) in 2019, 19 approvals (32%) in 2018, and 15 approvals (33%) in 2017 were given first-in-class designation…