Certara, a drug development consulting firm headquartered at Overlook Center, has helped its nonprofit client, Medicines Development for Global Health, to gain approval for a river blindness treatment for patients 12 and over.
The FDA approved MDGH’s new drug application for moxidectin on June 13, and MDGH has been granted a tropical disease priority review voucher.
“The phrase ‘Doing well by doing good’ epitomizes Certara’s culture and philosophy as we partner with the biopharma market to address public health challenges,” said Craig Rayner, senior vice president at Certara Strategic Consulting (CSC). “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. To have been selected by MDGH to support the development of moxidectin, an innovative and less burdensome treatment for onchocerciasis, was an honor 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,” said 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.” He added, “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 in 2015. A $13 million investment from the Global Health Investment Fund enabled MDGH to complete the Phase III trial, establish quality manufacturing to support registration, conduct an additional human study to complete the clinical data package, and prepare the comprehensive registration application for the FDA for moxidectin for river blindness.
Certara, 100 Overlook Center, Suite 101, Princeton 08540. 888-708-7444. Edmundo Muniz, chief executive officer. www.certara.com.