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Review
. 2019 Feb 23;24(4):809.
doi: 10.3390/molecules24040809.

The Pharmaceutical Industry in 2018. An Analysis of FDA Drug Approvals from the Perspective of Molecules

Beatriz G de la Torre  1 , Fernando Albericio  2   3
Affiliations
Review

The Pharmaceutical Industry in 2018. An Analysis of FDA Drug Approvals from the Perspective of Molecules

Beatriz G de la Torre et al. Molecules. .

Abstract

The Food and Drug Administration approved 59 new drugs (42 New Chemical Entities and 17 Biologics) during 2018. This number breaks the previous record of 53 approved by the same organization in 1996. The 17 new biologics approved in 2018 also represent an important milestone for this kind of drug and they clearly exceed the 12 approved in 2015 and 2017. Herein, the 59 new drugs of the class of 2018 are analyzed from a strictly chemical perspective. The classification has been carried out on the basis of the chemical structure and includes the following: Biologics (antibodies and enzymes); TIDES (peptides and oligonucleotides) and natural products; drug combinations; and small molecules.

Keywords: API; TIDES; antibodies; biologics; chemical entities; drug discovery; fluorine based drugs; natural products; oligonucleotides; peptide; small molecules.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
New chemical entities and biologics approved by the FDA in the last two decades [1,4,5].
Figure 2
Figure 2
Structure of oligonucleotide based drugs, patisiran and inotersen.
Figure 3
Figure 3
Structure of Lu 177 DOTA-TATE.
Figure 4
Figure 4
Structures of tetracycline drugs. In red the variable part.
Figure 5
Figure 5
Structure of carbohydrate derived drugs.
Figure 6
Figure 6
Structure of drugs containing a macrocycle.
Figure 7
Figure 7
Structure of AnnoveraTM, a combined steroid derived drug.
Figure 8
Figure 8
Structure of cannabidiol.
Figure 9
Figure 9
Structure of BiktarvyTM, a drug combination.
Figure 10
Figure 10
Structure of AkynzeoTM, a drug combination.
Figure 11
Figure 11
Structure of SymdekoTM, a drug combination.
Figure 12
Figure 12
Structure of apalutamide.
Figure 13
Figure 13
Structure of elagolix sodium.
Figure 14
Figure 14
Structure of doravirine, tafenoquine, and tecovirimat (* denotes a chiral center).
Figure 15
Figure 15
Structure of drugs for BRAF-mutated melanoma.
Figure 16
Figure 16
Structure of drugs for NSCLC.
Figure 17
Figure 17
Structure of drugs containing fluoroaryl moieties.
Figure 18
Figure 18
Structure of thiazol-2-amide (in red) containing molecules.
Figure 19
Figure 19
Structure of drugs for the treatment of acute myeloid leukemia.
Figure 20
Figure 20
Structure of baricitinib, duvelisib, and amifampridine.
Figure 21
Figure 21
Structure of stiripentol, lofexidine, prucalopride, and revefenacin. (* denotes a chiral center).
Figure 22
Figure 22
Drugs approved by the FDA in 2018 and classified on the basis of their chemical structure.
See this image and copyright information in PMC

References

    1. U.S. Food and Drug Administration (FDA) FDA Approved Drug Products. [(accessed on 20 February 2019)]; Available online: http://www.accessdata.fda.gov/scripts/cder/daf/
    1. Mullard A. 2017 FDA drug approvals. Nat. Rev. Drug Discov. 2018;17:81–85. doi: 10.1038/nrd.2018.4. - DOI - PubMed
    1. G. de la Torre B., Albericio F. An Analysis of FDA Drug Approvals from the Perspective of Molecules. Molecules. 2018;23:533. doi: 10.3390/molecules23030533. - DOI - PMC - PubMed
    1. Mullard A. 2018 FDA drug approvals. Nat. Rev. Drug Discov. 2019;18:85–89. doi: 10.1038/d41573-019-00014-x. - DOI - PubMed
    1. Jarvis L.M. The year in new drugs. Chem. Eng. News. 2018;96:26–30.

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