TDR’s long involvement with the development of drugs for neglected diseases took another positive step forward as Medicines Development for Global Health (MDGH) announced on 5 December 2024 that the Ghana Food and Drugs Authority (FDA) approved its marketing authorization application for moxidectin for the treatment of river blindness (onchocerciasis) in adults and children aged 4 years and older. This paves the way for a TDR-supported pilot implementation programme.
TDR, as part of the Access and Delivery Partnership (ADP), is collaborating with the Ghana Health Service, the University of Health and Allied Sciences in Ghana, the Bruyère Research Institute in Canada, MDGH and disease-endemic communities to evaluate the acceptability and feasibility of moxidectin distribution through community-based mass drug administration (MDA).
The results of this implementation research programme will add to the body of efficacy and safety data that formed the basis of the Ghana FDA approval and will inform WHO and endemic country decisions on the role of moxidectin in onchocerciasis elimination strategies. This work is an example of TDR’s engagement and collaboration with a wide range of partners to support implementation of new products and innovations.
Moxidectin development was initiated in the late 1990s by TDR in consultation with the Onchocerciasis Control Programme in West Africa (OCP) and the African Programme for Onchocerciasis Control (APOC). With funding from TDR and APOC donors, clinical studies were conducted as a collaboration between TDR, researchers in onchocerciasis endemic and other countries and WHO country offices. Following the withdrawal of TDR’s original for-profit pharmaceutical company partner and subsequent completion of the pivotal phase 3 study, TDR welcomed the decision of MDGH, a not-for-profit pharmaceutical company, to take on moxidectin.
In 2014, WHO licensed all moxidectin-related data at its disposal to MDGH, which took on the responsibility of achieving regulatory approval and making moxidectin available at an affordable cost to endemic countries. TDR continues to work with MDGH and researchers to raise funding and conduct additional clinical trials to inform WHO and endemic country decisions on inclusion of moxidectin in onchocerciasis elimination strategies, prequalification and regulatory approval and to disseminate the results to stakeholders. TDR also continues building and expanding clinical research and clinical research leadership capacity in the collaborating disease endemic country institutions.
In 2018, the United States of America Food and Drug Administration approved moxidectin for the treatment of onchocerciasis of individuals aged 12 years and older, the first new registration for the disease in 30 years. In 2023, the WHO Paediatric Drug Optimization initiative added moxidectin to the list of priority drugs for paediatric drug optimization for onchocerciasis and scabies.
For more information on this project, please contact Dr Corinne Merle.
This article was originally published in https://tdr.who.int