January 8, 2021

The U.S. FDA has approved 53 new drugs in 2020, nearing its record of 59 new approvals in one year, which was set in 2018.

Fifty-three new drug approvals would be a significant number under any circumstances, as it is the second highest in the history of the FDA. It is made even more significant by the COVID-19 pandemic, which has interfered with the FDA’s ability to conduct on-site inspections of drug manufacturing facilities. This has delayed some potential approvals that were expected in 2020 – such as inclisiran, an investigational cholesterol-lowering drug from Novartis.

At this time, it is uncertain whether the FDA will carry its recent trend of approving more than 40 novel drugs per year into 2021. The COVID-19 pandemic has not only disrupted FDA operations – it has also had an impact on late-stage clinical trials. Successful completion of late-stage trials is typically necessary for a new drug to gain FDA approval.

Of the new drugs approved in 2020, 21 are first-in-class therapies, 31 are indicated to treat rare diseases, and 36 used at least one of the FDA’s expedited development and review pathways for approval. The FDA’s full report on new drug approvals in 2020 can be found on the agency’s website.

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