Certara Drug Dev Role: FDA Approval of Moxidectin for River Blindness

Certara® has celebrated an important milestone for its public health drug development and treatment consulting portfolio. Certara was engaged by Medicines Development for Global Health (MDGH) to be a key part of its integrated drug development team to gain US Food and Drug Administration (FDA) approval for moxidectin, an 8 mg oral treatment for river blindness (onchocerciasis) in patients aged 12 years and older.

FDA approved MDGH’s new drug application for moxidectin on June 13, 2018 and MDGH has been granted a tropical disease priority review voucher. MDGH is the first not-for-profit company to achieve FDA approval as sole sponsor and also the first not for profit awarded a priority review voucher by the FDA.

HIV, tuberculosis, malaria, neglected tropical diseases (NTD) and viral hepatitis affect billions of people around the world, and cause more than 4 million deaths each year. The WHO Cluster for Communicable Diseases (CDS) is charged with the prevention and treatment of these high-burden diseases. Onchocerciasis is considered a NTD which are a group of parasitic and bacterial diseases that cause substantial illness for more than one billion people globally. 149 countries and territories are affected by at least one NTD.

Craig Rayner, PharmD, MBA, Senior Vice President at Certara Strategic Consulting (CSC) said, “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.”

Mark Sullivan Founder and Managing Director of MDGH said, “FDA approval is a momentous achievement for any biopharmaceutical company, but it is a particularly rare and exciting event in the neglected diseases setting.”