Food and Drug Administration Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development.

Area of Science:

• Pulmonary Medicine
• Infectious Diseases
• Drug Development

Background:

• Allergic bronchopulmonary aspergillosis and invasive fungal diseases cause significant illness and death.
• Current inhaled antifungal treatments lack approval, have limited effectiveness, and cause adverse effects.
• Antifungal resistance is an increasing concern in treating these pulmonary fungal infections.

Purpose of the Study:

• To address challenges in developing inhaled antifungal drugs for fungal lung diseases.
• To discuss regulatory incentives and improve nonclinical models and clinical trial designs.
• To gather insights from experts on patient perspectives and industry challenges.

Main Methods:

• Convened a US Food and Drug Administration (FDA) workshop on September 25, 2020.
• Brought together experts in pulmonary medicine and infectious diseases from academia, industry, and government.
• Focused discussions on regulatory, preclinical, and clinical trial aspects of inhaled antifungal development.

Main Results:

• Identified significant challenges in nonclinical models and clinical trial design for inhaled antifungals.
• Highlighted the need for regulatory incentives to foster development of new inhaled antifungal drugs and devices.
• Acknowledged the heterogeneity of patient populations and the low prevalence of these fungal diseases.

Conclusions:

• There is a critical need for improved inhaled antifungal therapies for pulmonary fungal infections.
• Addressing limitations in research models and clinical trial methodologies is essential for progress.
• Collaborative efforts and regulatory support are crucial to overcome barriers in developing effective inhaled antifungal treatments.