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

Elizabeth O'Shaughnessy; Yuliya Yasinskaya; Cheryl Dixon; Karen Higgins; Jason Moore; Kellie Reynolds; Neil M. Ampel; David Angulo; Janis E. Blair; Antonino Catanzaro; John N. Galgiani; Edward Garvey; Royce Johnson; David J. Larwood; Gareth Lewis; Rob Purdie; John H. Rex; Lisa Shubitz; David A. Stevens; Stephen J. Page; Sunita J. Shukla; John J. Farley; Sumathi Nambiar

doi:10.1093/cid/ciab904

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

Elizabeth O'Shaughnessy, Yuliya Yasinskaya, Cheryl Dixon, Karen Higgins, Jason Moore, Kellie Reynolds, Neil M. Ampel, David Angulo, Janis E. Blair, Antonino Catanzaro, John N. Galgiani, Edward Garvey, Royce Johnson, David J. Larwood, Gareth Lewis, Rob Purdie, John H. Rex, Lisa Shubitz, David A. Stevens, Stephen J. PageSunita J. Shukla, John J. Farley, Sumathi Nambiar

Research output: Contribution to journal › Review article › peer-review

4 Scopus citations

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.

Original language	English (US)
Pages (from-to)	2061-2066
Number of pages	6
Journal	Clinical Infectious Diseases
Volume	74
Issue number	11
DOIs	https://doi.org/10.1093/cid/ciab904
State	Published - Jun 1 2022

Keywords

antifungal drugs
coccidioidomycosis
drug development
rare diseases
valley fever

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

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O'Shaughnessy, E., Yasinskaya, Y., Dixon, C., Higgins, K., Moore, J., Reynolds, K., Ampel, N. M., Angulo, D., Blair, J. E., Catanzaro, A., Galgiani, J. N., Garvey, E., Johnson, R., Larwood, D. J., Lewis, G., Purdie, R., Rex, J. H., Shubitz, L., Stevens, D. A., ... Nambiar, S. (2022). FDA Public Workshop Summary - Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal Drugs. Clinical Infectious Diseases, 74(11), 2061-2066. https://doi.org/10.1093/cid/ciab904

O'Shaughnessy, E, Yasinskaya, Y, Dixon, C, Higgins, K, Moore, J, Reynolds, K, Ampel, NM, Angulo, D, Blair, JE, Catanzaro, A, Galgiani, JN, Garvey, E, Johnson, R, Larwood, DJ, Lewis, G, Purdie, R, Rex, JH, Shubitz, L, Stevens, DA, Page, SJ, Shukla, SJ, Farley, JJ & Nambiar, S 2022, 'FDA Public Workshop Summary - Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal Drugs', Clinical Infectious Diseases, vol. 74, no. 11, pp. 2061-2066. https://doi.org/10.1093/cid/ciab904

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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.",

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AB - 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.

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

Abstract

Keywords

ASJC Scopus subject areas

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