FDA Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development
Author:
Caroline J. Jjingo, Shukal Bala, Ursula Waack, Mark Needles, Timothy J. Bensman, Owen McMaster, Thomas Smith, Brandon Blakely,
Irene Z. Chan, Khalid Puthawala, Cheryl Dixon, Yongman Kim, Robert Lim, Philip Colangelo, Christopher St. Clair, Sumathi Nambiar,
Richard B. Moss, Radu Botgros, Rohit Bazaz, David W. Denning, Kieren A. Marr, Shahid Husain, Lance Berman, Dale J. Christensen,
Charlotte Keywood, Russell G. Clayton, Thomas J. Walsh, Hyo Sook E. Song, Sunita J. Shukla and John Farley
Date: 6 October 2023
Abstract:
Allergic bronchopulmonary aspergillosis and invasive fungal diseases represent distinct infectious entities that cause significant morbidity and mortality. Currently, administered inhaled antifungal therapies are unapproved, have suboptimal efficacy, and are associated with considerable adverse reactions. The emergence of resistant pathogens is also a growing concern. Inhaled antifungal development programs are challenged by inadequate nonclinical infection models, highly heterogenous patient populations, low prevalence rates of fungal diseases, difficulties defining clinical trial enrollment criteria, and lack of robust clinical trial endpoints. On September 25, 2020, the US Food and Drug Administration (FDA) convened a workshop with experts in pulmonary medicine and infectious diseases from academia, industry, and other governmental agencies. Key discussion topics included regulatory incentives to facilitate development of inhaled antifungal drugs and combination inhalational devices, limitations of existing nonclinical models and clinical trial designs, patient perspectives, and industry insights.
Keywords: antifungal agents; asthma; drug development; rare diseases.
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