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Analyzing US FDA-Approved Infectious Disease Drugs from 2015-2023
Get PDFPrimary Author: Rizamari May Pascua
Co-Authors: Tracy Pham, Dianqing Sun, PhD
Presentation Title: Analyzing US FDA-Approved Infectious Disease Drugs from 2015-2023
Purpose:
In 2019, there are approximately 10.2 million hospital visits for infectious and parasitic diseases in the
US. Because of emerging multi-drug resistance and public health threats, new drugs are urgently
needed to combat problematic bacterial, viral, fungal, and parasitic infections. The US Food and Drug
Administration (FDA) approved drugs play a crucial role in enhancing optimal patient care, improving
clinical outcome, and broadening treatment options. The objective of this study is to review all US FDA
approved infectious disease (ID) agents from 2015-2023 and analyze their medicinal chemistry
properties, mechanism of action, pharmacokinetic (PK) profiles, and clinical applications.
Methods:
This study utilized prescribing information and online open resources provided by the US FDA’s Center
for Drug Evaluation and Research (CDER). Drug information resources such as Lexicomp and Sanford
guide were searched for the dosing, route of administration, PK parameters, and indication of the
infectious disease medications. Physicochemical properties and Lipinski’s Rule of 5 such as molecular
weight, hydrogen bond donor, hydrogen bond acceptor, logP were obtained from ChemSpider &
Scifinder databases and subsequently analyzed to evaluate the oral bioavailability of these infectious
disease drugs and rationalize their routes of administration and clinical applications.
Results:
Based on the data collected from 2015-2023, the US FDA has approved a total of 49 novel infectious
disease agents including antiviral, antibacterial, antifungal, and antiparasitic. Specifically, 21 antiviral
agents were approved to address a wide spectrum of viral conditions, including 7 for human
immunodeficiency virus (HIV), 6 for hepatitis C virus (HCV), 2 for SARS-CoV-2, 2 for ebola virus, 1 for
respiratory syncytial virus (RSV), 1 for influenza virus, 1 for cytomegalovirus (CMV), and 1 for smallpox
virus. Additionally, 18 new antibacterial agents approved include 2 new chemotypes
(cephalosporin-siderophore conjugate antibiotic and anti-tuberculosis agent nitroimidazooxazine), 1
nitroimidazole, 2 fluoroquinolones, 1 rifamycin, 3 tetracyclines, 1 pleuromutilin, 1 aminoglycoside, 5
combination therapy (e.g., beta-lactam/beta-lactamase inhibitor), along with 2 biologic monoclonal
antibodies (mAbs). Furthermore, 6 antiparasitic agents and 4 antifungal agents have also been
approved since 2015. Notably, several of these agents have been subsequently discontinued from the
US market due to commercial and/or practice change reasons. Each of these agents will be
comprehensively discussed including chemical class, physicochemical property, mechanism of action,
route of administration, and dosing regimen. Further, detailed insights into their PK profiles (e.g., Tmax,
half-life, bioavailability, protein binding, metabolism, and excretion) will also be presented.
Conclusion:
Given rising (multi)drug-resistant microorganisms and evolving public health threats, there is an urgent,
unmet clinical need for developing new infectious disease drugs with novel mechanism of action. Since
2015, significant new medicine advances have been made in this field, leading to the US FDA approval
of 49 new chemical entity ID drugs. Thus, it is imperative for pharmacists, as drug and
pharmacotherapy experts, along with other healthcare professionals, to stay updated regarding these
new medication therapies, evaluate these expanded treatment options and provide optimal patient
care
Targeting Infection at the Source: evaluating the efficacy of semiochemical repellent compounds in the management of rapid ʻōhiʻa death-associated ambrosia beetles
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Interview with Prof. Kaliko Correa (Hawaiian Studies)
No full textThis interview, conducted by students in Professor Kim Compoc’s Fall 2024 Humanities 300 course at the University of Hawaiʻi – West Oʻahu, features Professor Mary-Lindsey Kalikolani Correa, Assistant Professor of Hawaiian and Pacific Studies. Professor Correa discusses her academic background, research, and the themes of aloha āʻina, Hawaiian political discourse, and cultural identity. She reflects on her dissertation, the origins and significance of her Aloha ʻĀina course, and her work in traditional Hawaiian learning spaces. The conversation covers personal connections to place, the protection of Mauna Kea, and the interdisciplinary nature of Hawaiian Studies