1. Food and Drug Administration Public Workshop Summary—Addressing Challenges in Inhaled Antifungal Drug Development.
- Author
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Jjingo, Caroline J, Bala, Shukal, Waack, Ursula, Needles, Mark, Bensman, Timothy J, McMaster, Owen, Smith, Thomas, Blakely, Brandon, Chan, Irene Z, Puthawala, Khalid, Dixon, Cheryl, Kim, Yongman, Lim, Robert, Colangelo, Philip, Clair, Christopher St., Nambiar, Sumathi, Moss, Richard B, Botgros, Radu, Bazaz, Rohit, and Denning, David W
- Subjects
ANTIFUNGAL agents ,BIOLOGICAL models ,ASPERGILLOSIS ,RARE diseases ,CLINICAL trials ,ALLERGIES ,TREATMENT effectiveness ,INHALATION administration ,DRUG approval ,ADULT education workshops ,DRUG efficacy ,DRUG development ,PHARMACODYNAMICS - 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 25 September 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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