Ghana becomes first river blindness-endemic country to approve moxidectin

Melbourne, Australia and Accra, Ghana

‍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 blindness 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.

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About River Blindness

River blindness is caused by the parasitic worm Onchocerca volvulus, which is transmitted from person to person by black flies that breed in fast flowing rivers, primarily in Africa. The association of rivers and streams, together with the worst manifestation of O. volvulus infection, blindness, led to the adoption of the more commonly known term for the disease, “river blindness”. The millions of larvae (microfilariae) released by the adult parasites invade skin and eyes where they can cause severe manifestations, including permanent blindness, itching and disfiguring skin conditions. More than 200 million people are at risk of infection and almost all infected people live in 29 African countries.

River blindness elimination programs rely on the public health strategy known as mass drug administration or community directed treatment, in which the whole eligible population in endemic areas receives ivermectin, regardless of infection status. Ivermectin (Mectizan®), has been donated by Merck (known as MSD outside the United States and Canada) to endemic countries for over 30 years. Ivermectin has significantly reduced the disease burden, but new treatment options are needed to accelerate progress toward eliminating parasite transmission.

About Moxidectin

Moxidectin is a macrocyclic lactone anthelmintic medicine that selectively binds to the parasite's glutamate-gated chloride ion channels. These channels are vital to the function of invertebrate nerve and muscle cells. At a single dose, moxidectin has activity against O. volvulus microfilariae but does not kill adult O. volvulus parasites.

Patients with river blindness administered moxidectin experienced adverse events consistent with those associated with efficacy. The nature and severity of adverse events in moxidectin recipients was similar to those in ivermectin recipients. The most common adverse reactions (incidence > 10%) were: eosinophilia, pruritus, musculoskeletal pain, headache, lymphopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, lymph node pain, dizziness, diarrhea, hyponatremia and peripheral swelling.

Moxidectin is approved by the US FDA for the treatment of onchocerciasis due to Onchocerca volvulus in patients 12 years and older and is approved by the Ghana FDA for the treatment of people aged 4 years and older. The efficacy of annual and biannual administrations of single doses of moxidectin is being addressed in an ongoing Phase 3b/4 clinical trial in the Democratic Republic of Congo (NCT03876262; PACTR202004639229710).

Please see full Prescribing Information, available at Drugs@FDA

About Medicines Development for Global Health

MDGH is a not-for-profit pharmaceutical company dedicated to the development and delivery of new and improved medicines for diseases that disproportionately affect people in low- and middle-income countries.

In 2014, MDGH received a license from WHO (which had initiated and led moxidectin development for onchocerciasis through TDR), for all data at its disposal to support the registration of moxidectin and make it available to endemic countries. In 2018, MDGH achieved United States Food and Drug Administration approval of moxidectin for the treatment of river blindness (onchocerciasis), and is currently developing moxidectin for the treatment of several other neglected tropical diseases.

In 2020, the company assumed full responsibility for the development and commercialisation of dovramilast from Amgen for both tuberculosis and leprosy type 2 reaction. Further information is available at www.medicinesdevelopment.com.

Partners

MDGH acknowledges the many partners who have contributed directly or indirectly to this outcome, including, The Access and Delivery Partnership, Argenta, Atticus Medical Pty Ltd, Bridges to Development, The Bruyère Research Institute, Centre de Recherche en Maladies Tropicales (CRMT) de l’Ituri, The Centre for Research on Filariasis and other Tropical Diseases (CRFilMT), Certara, The Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Project, Erasmus University Rotterdam, The European and Developing Countries Clinical Trials Partnership, The Ghana Health Service, The Global Health Investment Fund, The Global Institute for Disease Elimination, Imperial College London, Institut de Recherche pour le Développement, The Leona M. and Harry B. Helmsley Charitable Trust, The Luxembourg Institute of Health, The Luxembourg National Research Fund, The Onchocerciasis Clinical Research Centre Ghana, the many scientists at Wyeth/Pfizer, The Swiss Tropical and Public Health, TDR, The University Hospital Bonn, The University of Health and Allied Sciences, and The University of Strathclyde.

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Media Contact

Dr George Rugarabamu

+61 3 9912 2421

grugarabamu@MDGH.com

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