Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need
Author:
Yuliya Yasinskaya, Shukal Bala, Ursula Waack, Cheryl Dixon, Karen Higgins, Jason N. Moore, Caroline J. Jjingo, Elizabeth O’Shaughnessy, Philip Colangelo, Radu Botgros, Sumathi Nambiar, David Angulo, Aaron Dane, Tom Chiller, Michael R. Hodges, Taylor Sandison, William Hope, Thomas J. Walsh, Peter Pappas, Aspasia Katragkou, Laura Kovanda, John H. Rex, Kieren A. Marr, Luis Ostrosky-Zeichner, Shohko Sekine, Monika Deshpande, Sunita J. Shukla, and John Farley
Date: 6 April 2023
Abstract:
Pressing challenges in the treatment of invasive fungal infections (IFI) 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 (e.g., pediatrics); and heterogeneity of the IFIs. On August 4, 2020, the U.S. 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 paper 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.
Keywords: aspergillosis; candidiasis; drug development; mucormycosis; regulatory.
Download the full article (Disclaimer)
This manuscript library of ~16,000 articles (1729-2024) related to Aspergillus and aspergillosis is intended for individual study only, and is provided as contribution to global understanding of the topic. Please refer to the publisher’s guidance about any other usage.