Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need.
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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, Kovanda Laura, Rex John H, Marr Kieren A, Ostrosky-Zeichner Luis, Sekine Shohko, Deshpande Monika, Shukla Sunita J, Farley John
Аннотация
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.