A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

Abstract

While new drug approvals by the U.S. Food and Drug Administration (FDA) had remained stable or even increased in the first 2 years of the COVID-19 pandemic, the 37 newly approved drugs in 2022 are considerably less than the 53 and 50 new drugs approved in 2020 and 2021, respectively, and less than the rolling 10-year average of 43. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition (“first-in-indication”), first drug using a novel molecular mechanism (“first-in-class”), and “next-in-class,” i.e., a drug using an already exploited molecular mechanism. We identify two “first-in-indication” (ganaxolon and teplizumab), 20 (54%) “first-in-class,” and 17 (46%) “next-in-class” drugs. By treatment area, rare diseases and cancer drugs were once again the most prevalent (partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics).

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2023

“…The number of novel drugs approved by the FDA in 2023 was similar to that in the past several years (Kayki-Mutlu and Michel 2021; Kayki-Mutlu et al 2022), except the pandemic-related dent observed in 2022 (Kayki-Mutlu et al 2023). The share of small molecules among new drug approvals has continuously declined in the past 4 years from 70% in 2020 to 49% in 2023.…”

“…Our analyses follow the same protocol as those for newly approved drugs in 2020–2022 (Kayki-Mutlu and Michel 2021 ; Kayki-Mutlu et al 2022 , 2023 ) with one exception. Unlike in previous years, we have included cellular and gene therapies approved by the FDA (U.S. Food and Drug Administration 2023a , b ) into our analysis.…”

“…A long-acting G-CSF was developed using fusion protein technology (Blair 2023a ). The first long-acting G-CSF product, eflapegrastim-xnst, was approved by the FDA last in 2022 (Kayki-Mutlu et al 2023 ). In 2023, efbemalenograstim alfa-vuxw has been approved to reduce the incidence of infections with febrile neutropenia in adult patients with non-myeloid malignancies who are receiving myelosuppressive therapy and are at risk of developing febrile neutropenia.…”

“…Analyzing patterns of new drug approval testifies to the activities and priorities of the pharmaceutical industry and provides information on trends in novel treatment approaches. The US Food and Drug Administration (FDA) approved 37 new molecular entities in 2022 (Kayki-Mutlu et al 2023 ), 50 in 2021 (Kayki-Mutlu et al 2022 ), and 53 in 2020 (Kayki-Mutlu and Michel 2021 ). The dip in new approvals in 2022 apparently reflected reduced trial completions and regulatory filings during the COVID-19 pandemic.…”