Food and Drug Administration (FDA) Public Workshop Summary—Addressing Challenges in Inhaled Antifungal Drug Development

Author:

Jjingo Caroline J1,Bala Shukal1,Waack Ursula1,Needles Mark1,Bensman Timothy J2,McMaster Owen3,Smith Thomas1,Blakely Brandon4,Chan Irene Z5,Puthawala Khalid6,Dixon Cheryl7,Kim Yongman8,Lim Robert6,Colangelo Philip2,St. Clair Christopher9,Nambiar Sumathi1,Moss Richard B10,Botgros Radu11,Bazaz Rohit12,Denning David W13,Marr Kieren A14,Husain Shahid15,Berman Lance16,Christensen Dale J17,Keywood Charlotte18,Clayton Russell G19,Walsh Thomas J2021,Song Hyo Sook E22,Shukla Sunita J23,Farley John23

Affiliation:

1. Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

2. Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

3. Division of Pharmacology/Toxicology for Infectious Diseases, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

4. Division of ENT, Sleep, Respiratory, and Anesthesia, Office of Health Technology 1, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration , Silver Spring, Maryland , USA

5. Division of Medication Error Prevention and Analysis, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

6. Division of Pulmonology, Allergy, and Critical Care, Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

7. Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

8. Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

9. Division of Clinical Outcome Assessment, Office of Drug Evaluation Science, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

10. Department of Pediatrics, Lucile Packard Children's Hospital and Stanford Children's Health, Stanford University Medical Center , Palo Alto, California , USA

11. Office of Biological Health Threats and Vaccines Strategy, European Medicines Agency , Amsterdam , The Netherlands

12. National Aspergillosis Centre, University of Manchester , Manchester , United Kingdom

13. Global Action Fund for Fungal Infections, The University of Manchester , Manchester , United Kingdom

14. Department of Medicine, Johns Hopkins University , Baltimore, Maryland , USA

15. Transplant Infectious Diseases Clinic, University Health Network, University of Toronto , Toronto, Ontario , Canada

16. Pulmocide , London , United Kingdom

17. TFF Pharmaceuticals , Fort Worth, Texas , USA

18. Zambon SpA , Milan , Italy

19. Aeremedea LLC , Fenandina Beach, Florida , USA

20. Transplantation-Oncology Infectious Diseases Program, Weill Cornell Medicine , New York, New York , USA

21. Save Our Sick Kids Foundation , New York, New York , USA

22. DRT Strategies , Arlington, Virginia , USA

23. Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland , USA

Abstract

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.

Funder

Center for Drug Evaluation and Research

US Food and Drug Administration

TFF Pharmaceuticals

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Antifungal Resistance in Pulmonary Aspergillosis;Seminars in Respiratory and Critical Care Medicine;2024-01-09

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