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

Clin Infect Dis. 2022 Jun 10;74(11):2061-2066. doi: 10.1093/cid/ciab904.

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.

Keywords: antifungal drugs; coccidioidomycosis; drug development; rare diseases; valley fever.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antifungal Agents / therapeutic use
  • Coccidioides
  • Coccidioidomycosis* / drug therapy
  • Coccidioidomycosis* / epidemiology
  • Coccidioidomycosis* / microbiology
  • Humans
  • Prevalence
  • United States / epidemiology
  • United States Food and Drug Administration

Substances

  • Antifungal Agents