Posted: 10 December 2024
Medicines Development for Global Health (MDGH) announced today that the Ghana Food and Drugs Authority (FDA) has approved the marketing authorisation application for moxidectin 2 mg oral tablets for the treatment of river blindness (onchocerciasis) in adults and children aged 4 years and older.
Ghana is the first river blindness-endemic country to grant regulatory approval of moxidectin, clearing the way for the planned community pilot treatment implementation program, MOMENTUM, to begin in the Twifo Atti-Morkwa district in January 2025. The MOMENTUM pilot program is a collaboration between 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.
River blindness is a debilitating and disfiguring disease caused by the parasitic worm, Onchocerca volvulus. The worm’s larvae, microfilariae, cause severe itching, significant skin changes and can lead to visual impairment, including permanent blindness, and are the source of transmission in a community. World Health Organization and endemic countries target elimination of parasite transmission, currently primarily through mass administration of ivermectin. Moxidectin has been shown to reduce skin microfilariae levels more profoundly and for longer than ivermectin and is thus expected to accelerate elimination of parasite transmission.
This approval marks an important step forward in efforts towards elimination goals. The Twifo Atti-Morkwa district was identified by the Ghana Health Service as a priority area for moxidectin after higher-than-expected disease prevalence was found following multiple rounds of ivermectin mass administration.
“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” said Mark Sullivan, Managing Director of MDGH. “This is a new model – it is the first time a not-for-profit company has achieved regulatory approval and will deliver a completely novel medicine into an endemic country without the involvement of a multinational pharmaceutical company or generic company partner. Ghana has shown leadership in the evaluation of moxidectin and we have been delighted to support them.”
Sally Kinrade, Vice President and Project Leader, onchocerciasis and lymphatic filariasis said:
“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. We are grateful to the many people and organisations that have contributed to achieving this milestone, in particular the research community in Ghana. 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.”
On 13 June 2018, MDGH obtained United States Food and Drug Administration (US FDA) approval of moxidectin 2 mg oral tablets for the treatment of river onchocerciasis in patients aged 12 years and older.
MDGH will be providing moxidectin tablets at cost-plus pricing (without profit) for use in low- and middle-income countries. Discussions are underway with the community of stakeholders working for river blindness elimination to determine how best moxidectin will be utilised to help achieve elimination goals and to inform the potential demand.
MDGH acknowledges the many partners who have contributed to the development and delivery of moxidectin, in particular the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Disease (TDR), which initiated and led moxidectin development until 2014 when it turned over sponsorship to MDGH. TDR is part of the Access and Delivery Partnership for the MOMENTUM pilot program.
