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FDA Public Workshop Summary-Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal Drugs.

Authors
  • O'Shaughnessy, Elizabeth1
  • Yasinskaya, Yuliya1
  • Dixon, Cheryl2
  • Higgins, Karen2
  • Moore, Jason3
  • Reynolds, Kellie3
  • Ampel, Neil M4
  • Angulo, David5
  • Blair, Janis E6
  • Catanzaro, Antonino7
  • Galgiani, John N4
  • Garvey, Edward8
  • Johnson, Royce9
  • Larwood, David J10
  • Lewis, Gareth11
  • Purdie, Rob9
  • Rex, John H12
  • Shubitz, Lisa F4
  • Stevens, David A13
  • Page, Stephen J14
  • And 3 more
  • 1 Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • 2 Division of Biometrics IV, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA.
  • 3 Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, CDER, FDA, Silver Spring, Maryland, USA.
  • 4 Valley Fever Center for Excellence, University of Arizona, Tucson, Arizona, USA.
  • 5 SCYNEXIS, Inc., Jersey City, New Jersey, USA. , (Jersey)
  • 6 Mayo Clinic, Phoenix, Arizona, USA.
  • 7 University of California, San Diego, La Jolla, California, USA.
  • 8 Mycovia Pharmaceuticals, Inc., Durham, North Carolina, USA.
  • 9 Valley Fever Institute, Kern Medical, Bakersfield, California, USA.
  • 10 Valley Fever Solutions, Inc., Tucson, Arizona, USA.
  • 11 Mayne Pharma, Raleigh, NC, USA.
  • 12 F2G, Ltd., Manchester, United Kingdom. , (United Kingdom)
  • 13 California Institute for Medical Research, San Jose, California, and Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • 14 DRT Strategies, Inc., Arlington, Virginia, USAand.
  • 15 Office of Infectious Diseases, Office of New Drugs, CDER, FDA, Silver Spring, Maryland, USA.
Type
Published Article
Journal
Clinical Infectious Diseases
Publisher
Oxford University Press
Publication Date
Jun 10, 2022
Volume
74
Issue
11
Pages
2061–2066
Identifiers
DOI: 10.1093/cid/ciab904
PMID: 34651656
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Coccidioidomycosis is a fungal disease endemic to the southwestern United States, Mexico, and Central and South America. Prevalence rates are increasing steadily, and new endemic areas of Coccidioides are emerging. Standard treatment is often administered for months to decades, and intolerance to medications and treatment failures are common. No new treatments for coccidioidomycosis have been approved in the United States in nearly 40 years. On 5 August 2020, the US Food and Drug Administration convened experts in coccidioidomycosis from academia, industry, patient groups, and other government agencies to discuss the disease landscape and strategies to facilitate product development for treatment of coccidioidomycosis. This article summarizes the key topics concerning drug development for coccidioidomycosis presented by speakers and panelists during the workshop, such as unmet need, trial designs, endpoints, incentives, research and development support, and collaborations to facilitate antifungal drug development. Published by Oxford University Press for the Infectious Diseases Society of America 2021.

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