The Ghana Food and Drugs Authority (FDA) has approved moxidectin 2 mg oral tablets for the treatment of river blindness (onchocerciasis) in adults and children aged 4 years and older. This makes Ghana the first river blindness-endemic country to grant regulatory approval to moxidectin, paving the way for its use in eliminating the disease. The approval was announced by Medicines Development for Global Health (MDGH).
MOMENTUM Pilot Program
The planned community pilot treatment implementation program, MOMENTUM, is scheduled to commence in the Twifo Atti-Morkwa district in January 2025. This program is a collaborative effort involving the Ghana Health Service, the University of Health and Allied Sciences in Ghana, the Bruyère Research Institute in Canada, the Access and Delivery Partnership, and MDGH. The Twifo Atti-Morkwa district was identified as a priority area due to higher-than-expected disease prevalence despite multiple rounds of ivermectin mass administration.
Significance of Moxidectin
River blindness, caused by the parasitic worm Onchocerca volvulus, leads to severe itching, skin changes, and potential visual impairment, including permanent blindness. The current strategy for eliminating parasite transmission primarily involves mass administration of ivermectin. Moxidectin has demonstrated a more profound and longer-lasting reduction in skin microfilariae levels compared to ivermectin, suggesting it could accelerate the elimination of parasite transmission.
MDGH's Role and Pricing
Mark Sullivan, Managing Director of MDGH, emphasized the significance of this approval, stating, "This approval by the Ghana FDA is a significant milestone – it marks MDGH’s first registration of moxidectin in a country disproportionately affected by neglected tropical diseases." MDGH will provide moxidectin tablets at cost-plus pricing (without profit) for use in low- and middle-income countries. Discussions are ongoing with stakeholders to determine the optimal utilization of moxidectin in achieving elimination goals and to assess potential demand.
History of Moxidectin Development
The development of moxidectin for treating river blindness spans over 25 years. Sally Kinrade, Vice President and Project Leader, onchocerciasis and lymphatic filariasis, noted, "This approval is the culmination of more than 25 years in the development of moxidectin for the treatment of river blindness and other human diseases... It is fitting that Ghanaian communities will be the first to benefit from the implementation of moxidectin to help progress their disease elimination goals given that the first study of moxidectin in infected people was conducted in Ghana." The US FDA approved moxidectin 2 mg oral tablets for treating river onchocerciasis in patients aged 12 years and older on June 13, 2018. MDGH acknowledges the contributions of partners, particularly the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Disease (TDR), which initiated and led moxidectin development until 2014.
