Moxidectin for Women’s Health Equity

Model-Informed Drug Development is increasingly impacting public health and regulatory decision-making in support of global health initiatives. In this webinar, we share a recent global health case study on the use of pharmacokinetic (PK) and physiologically based pharmacokinetic (PBPK) modeling of moxidectin to understand the impact of drug exposure on breastfed infants. We discuss how these quantitative approaches, which complement clinical lactation data, offered insights for healthcare providers, policymakers, and regulatory bodies while laying the groundwork for scalable solutions in global health challenges.

Moxidectin, a groundbreaking drug 25 years in development, gained FDA approval in 2018 for treating onchocerciasis (river blindness) in individuals aged 12 and older. More recently, the Ghana Food and Drugs Authority (FDA)  approved its marketing authorization application for moxidectin for the treatment of river blindness in adults and children aged 4 years and older. As a key component in mass drug administration (MDA) programs, addressing the needs of breastfeeding women is essential for equitable and effective care in endemic regions.

Breastfeeding is common in communities affected by onchocerciasis, and many women participate in MDA programs while lactating. Developing safe, scientifically informed dosing recommendations is vital to protecting maternal and infant health.

Key Takeaways

Global Health Impact: PK and PBPK modeling plays an influential role in ensuring safe, equitable care for understudied populations.

Scalable Framework: Model-Informed Drug Development (MIDD) provides a replicable approach to address underserved populations and advance equitable healthcare worldwide.

Lactation Safety: Data-driven guidance can support effective maternal and infant care.

Evidence-Based Dosing: Combining clinical and modeling data establishes safe, effective dosing, advancing health equity globally.

Stakeholder Empowerment: Actionable insights support prescribers, policymakers, and regulators in improving maternal and infant health outcomes during drug development.

What You’ll Learn

How MIDD influences public health and regulatory decision-making at local and global levels.

• The role of modeling in ensuring safe treatments for populations including breastfeeding and pediatric populations.
• Strategies for addressing drug-drug interactions and optimizing therapies in MDA programs.
• Broader applications of quantitative pharmacology in advancing global health initiatives.
• How to use quantitative evidence to accelerate regulatory approvals.