Certara supports MDGH team to gain FDA approval for moxidectin

Certara — decision support technology and consulting organisation — has celebrated an important milestone for its public health drug development and treatment consulting portfolio after it had successfully supported the team that gained FDA approval for moxidectin.

Moxidectin is an 8 mg oral treatment for river blindness (onchocerciasis) in patients aged 12 years and older that has been developed by Medicines Development for Global Health (MDGH) — a not-for-profit biotechnology company. The FDA approved MDGH’s new drug application for moxidectin earlier this month (13 June) and has granted the company a tropical disease priority review voucher.

“Onchocerciasis is the second leading cause of infectious blindness and the fourth leading cause of preventable blindness worldwide. It is endemic in some of the world’s poorest and most disadvantaged communities, affecting at least 25 million people worldwide,” said Craig Rayner, PharmD, MBA, senior vice president at Certara Strategic Consulting (CSC). “To have been selected by MDGH to support the development of moxidectin, an innovative and less burdensome treatment for onchocerciasis, was an honour for our team. We thank MDGH for this opportunity.”

“FDA approval is a momentous achievement for any biopharmaceutical company, but it is a particularly rare and exciting event in the neglected diseases setting,” commented Mark Sullivan, founder and managing director of MDGH. “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.”

MDGH secured the rights to develop moxidectin for human use from the WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) in 2015.