Supporting the Approval of a Treatment for a Neglected Tropical Disease
Certara scientists were key members of the Medicines Development for Global Health (MDGH) development team that achieved FDA approval of moxidectin for river blindness. MDGH needed integrated, model-informed drug development expertise to support the development of moxidectin as an oral treatment for onchocerciasis.
Certara provided expertise, including governance committee membership, leadership of clinical pharmacology and pharmacometrics, and support for translational medicine, regulatory science, and strategy activities. Certara’s approach yielded a significant financial, scientific, and regulatory ROI to MDGH, culminating in FDA approval and receipt of a tropical disease priority review voucher.
It takes a broad community to develop a new medicine, and the FDA approval represents decades of work by thousands of scientists, disease control specialists, expert advisors, community health workers, funders and study participants. The Certara team were (and remain) tremendous collaborators and were very much part of our team.
Mark Sullivan Founder and managing director of Medicines Development for Global Health (MDGH) on the approval of moxidectin for river blindness (onchocerciasis)
MDGH is an independent not-for-profit biopharmaceutical company headquartered in Melbourne, Australia. Established in 2005, this unique organization is dedicated to the development of affordable medicines and vaccines for infectious and neglected diseases prevalent in low- and middle-income countries.