학술논문
Food and Drug Administration Public Workshop Summary—Development Considerations of Antifungal Drugs to Address Unmet Medical Need.
Document Type
Article
Author
Yasinskaya, Yuliya; Bala, Shukal; Waack, Ursula; Dixon, Cheryl; Higgins, Karen; Moore, Jason N; Jjingo, Caroline J; O'Shaughnessy, Elizabeth; Colangelo, Philip; Botgros, Radu; Nambiar, Sumathi; Angulo, David; Dane, Aaron; Chiller, Tom; Hodges, Michael R; Sandison, Taylor; Hope, William; Walsh, Thomas J; Pappas, Peter; Katragkou, Aspasia
Source
Subject
*ANTIFUNGAL agents
*CLINICAL trials
*ENDOWMENT of research
*MYCOSES
*GOVERNMENT agencies
*INTERPROFESSIONAL relations
*DRUG development
*MEDICAL needs assessment
*ADULT education workshops
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Language
ISSN
1058-4838
Abstract
Pressing challenges in the treatment of invasive fungal infections (IFIs) include emerging and rare pathogens, resistant/refractory infections, and antifungal armamentarium limited by toxicity, drug-drug interactions, and lack of oral formulations. Development of new antifungal drugs is hampered by the limitations of the available diagnostics, clinical trial endpoints, prolonged trial duration, difficulties in patient recruitment, including subpopulations (eg, pediatrics), and heterogeneity of the IFIs. On 4 August 2020, the US Food and Drug Administration convened a workshop that included IFI experts from academia, industry, and other government agencies to discuss the IFI landscape, unmet need, and potential strategies to facilitate the development of antifungal drugs for treatment and prophylaxis. This article summarizes the key topics presented and discussed during the workshop, such as incentives and research support for drug developers, nonclinical development, clinical trial design challenges, lessons learned from industry, and potential collaborations to facilitate antifungal drug development. [ABSTRACT FROM AUTHOR]