In 2022, the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 37 new drugs that were never before approved or marketed in the United States, 99 first-time generic approvals, and seven new biosimilar products. The number of new drugs for 2022 was the lowest since 2016, when only 22 drugs were approved.
The number of drug applications CDER received in 2022 was similar to the past few years (and higher than historical norms), demonstrating that innovation remains strong in the drug development sector. From 2013 through 2022, CDER averaged about 43 novel drug approvals each year.
While no official reason for the decline in approvals has been issued, one may consider the 2021 approval of Aduhelm, which ultimately led to the resignation of three panelists from an independent drug review board, and may perhaps presume that the Agency intentionally moved slower in 2022 to avoid the appearance of moving too quickly on drug approvals.
However, despite the decline in new drug approvals, the FDA focused on achievements such as revised pathways for enhanced and expedited drug review. For example, CDER approved 28 of the 37 drugs on the “first cycle” of review. Additionally, fast track status was granted to 12 of the 37 drugs – including six that made use of the accelerated approval process.
Patrizia Cavazzoni, MD, Director of CDER, said “Our report highlights CDER’s novel approvals of 2022 that will make a difference in people’s lives. The report also illustrates the ways we evaluated drug safety and efficacy, as well as the regulatory tools we used to review and approve drug applications. We approved almost all of these therapies on or before their goal dates, or congressionally authorized agreements with industry. More than half were approved in the U.S. before any other country.”
2022 Drug Approvals
Of the 37 new drug approvals in 2022, 20 were first-in-class, 20 were approved to treat orphan diseases, and 25 were approved in the United States before approved in any other country. The 99 first-time generic approvals in 2022 was greater than generic approvals in the prior two years.
Drugs approved in 2022 (including novel drug approvals and drugs approved in new settings) target diseases and conditions such as infectious diseases (i.e., HIV, smallpox, and H. pylori), amyotrophic lateral sclerosis (ALS), type 1 diabetes and type 2 diabetes, lupus nephritis, psoriasis, and various cancers.
Additionally, 20 of the 37 new drug approvals were for rare diseases, including Niemann-Pick disease type A, B, A/B; generalized pustular psoriasis; obstructive hypertrophic cardiomyopathy; metastatic or unresectable uveal melanoma; and hepatorenal syndrome.
2022 Biosimilar Approvals
2022 also saw the approval of the 40th biosimilar and seven biosimilars approved overall, including 2 interchangeable biosimilars. The approved biosimilars target diseases and conditions such as neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic retinopathy, inflammatory conditions, febrile neutropenia, and multiple cancer indications.