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Review
. 2021 Jan 25;26(3):627.
doi: 10.3390/molecules26030627.

The Pharmaceutical Industry in 2020. An Analysis of FDA Drug Approvals from the Perspective of Molecules

Affiliations
Review

The Pharmaceutical Industry in 2020. An Analysis of FDA Drug Approvals from the Perspective of Molecules

Beatriz G de la Torre et al. Molecules. .

Abstract

Although the pharmaceutical industry will remember 2020 as the year of COVID-19, it is important to highlight that this year has been the second-best-together with 1996-in terms of the number of drugs accepted by the US Food and Drug Administration (FDA). Each of these two years witnessed the authorization of 53 drugs-a number surpassed only in 2018 with 59 pharmaceutical agents. The 53 approvals in 2020 are divided between 40 new chemical entities and 13 biologic drugs (biologics). Of note, ten monoclonal antibodies, two antibody-drug conjugates, three peptides, and two oligonucleotides have been approved in 2020. Close inspection of the so-called small molecules reveals the significant presence of fluorine atoms and/or nitrogen aromatic heterocycles. This report analyzes the 53 new drugs of the 2020 harvest from a strictly chemical perspective, as it did for those authorized in the previous four years. On the basis of chemical structure alone, the drugs that received approval in 2020 are classified as the following: biologics (antibodies, antibody-drug conjugates, and proteins); TIDES (peptide and oligonucleotides); natural products; fluorine-containing molecules; nitrogen aromatic heterocycles; and other small molecules.

Keywords: API; CBER; CDER; COVID-19; TIDES; antibodies; antibody–drug conjugate; biologics; chemical entities; drug discovery; fluorine-based drugs; natural products; nitrogen aromatic heterocycles; oligonucleotides; peptides; small molecules.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Drugs (New Chemical Entities and Biologics) approved by the FDA in the last two decades [1].
Figure 2
Figure 2
Structure of belantamab mafodotin-blm.
Figure 3
Figure 3
Structure of sacituzumab govitecan-hziy.
Figure 4
Figure 4
Structure of setmelanotide.
Figure 5
Figure 5
Structure of Cu-64 dotatate.
Figure 6
Figure 6
Structure of Ga-68 PSMA-1.
Figure 7
Figure 7
Structure of viltolarsen.
Figure 8
Figure 8
Structure of lumasiran.
Figure 9
Figure 9
Structure of the natural product-based drugs (in blue fluorine atoms).
Figure 10
Figure 10
Structure of fostemsavir.
Figure 11
Figure 11
Structure of drugs containing one fluoroaryl moiety (fluorine atoms shown in blue).
Figure 12
Figure 12
Structure of drugs containing more than one fluorine (fluorine atoms shown in blue).
Figure 13
Figure 13
Structure of drugs containing nitrogen aromatic heterocycles.
Figure 14
Figure 14
Structure of drugs containing pyridine moieties.
Figure 15
Figure 15
Structure of nifurtimox, amisulpride, and bempedoic acid. * Mixture of Z/E conformers
Figure 16
Figure 16
Drugs approved by the FDA in 2020 classified on the basis of their chemical structure (drugs can belong to two distinct classes).

References

    1. U.S. Food and Drug Administration (FDA) [(accessed on 31 December 2020)]; Available online: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and....
    1. De La Torre B.G., Albericio F. The Pharmaceutical Industry in 2019. An Analysis of FDA Drug Approvals from the Perspective of Molecules. Molecules. 2020;25:745. doi: 10.3390/molecules25030745. - DOI - PMC - PubMed
    1. Mullard A. 2019 FDA drug approvals. Nat. Rev. Drug Discov. 2020;19 doi: 10.1038/d41573-020-00001-7. - DOI - PubMed
    1. Jarvis L.M. The new drugs of 2019. [(accessed on 20 January 2020)];Chem. Eng. News. 2020 98:30–36. Available online: https://cen.acs.org/pharmaceuticals/drug-development/new-drugs-2019/98/i3.
    1. U.S. Food and Drug Administration (FDA) [(accessed on 1 January 2021)]; Available online: https://www.fda.gov/vaccines-blood-biologics/development-approval-proces....

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