Ghana rolls out moxidectin, a new treatment for river blindness

Melbourne, Australia and Accra, Ghana

For the first time anywhere in the world, moxidectin is being used in the community-based treatment of onchocerciasis (river blindness). Ghana Health Service has commenced the mass drug administration (MDA) of moxidectin in the Twifo Atti Morkwa district, an area with ongoing river blindness transmission despite many years of prior ivermectin treatment.

The community-based MDA campaign, known as the Momentum Project, follows the Ghana Food and Drugs Authority’s (FDA) approval of moxidectin for the treatment of river blindness in adults and children aged 4 years and older in November 2024. In preparation for the campaign, the first shipment of over 250,000 doses of moxidectin arrived in Ghana in December.

Over the next three years, Ghana Health Service will distribute moxidectin to the Twifo Atti Morkwa community every six months. Dedicated community volunteers will lead engagement efforts and door-to-door distribution of moxidectin to help reduce, and hopefully cease, the transmission and prevalence of river blindness.

The Project will also include a social research study, conducted by Ghana’s University of Health and Allied Sciences (UHAS) and the Bruyère Research Institute in Canada, to evaluate the acceptability and feasibility of moxidectin distribution through community-based MDA.

Mark Sullivan AO, Managing Director of Medicines Development for Global Health (MDGH), said:

“Moxidectin has the potential to be one of the most transformative medicines in global health and this is a poignant moment for the MDGH team, who have spent the last 10 years developing it. This milestone would not have been possible without the vision and leadership of the Special Programme for Research and Training in Tropical Disease (TDR), who have helped to shepherd the development of moxidectin for almost 20 years. We are deeply grateful to the many individuals and organisations who have contributed to this milestone, especially the Ghanaian and other endemic countries public health and research communities and, of course, the people who participated in many trials over many years. Moxidectin is a great example of the reason that MDGH exists – to bring life changing new medicines to communities affected by neglected diseases, where market driven models have failed.”

Dr Joseph Opare of the Ghana Health Service Neglected Tropical Diseases Programme, said:

“Ghana is excited to experience mass drug administration with moxidectin in one district in the Central Region of Ghana. Inspired by recent successes, the onchocerciasis control policy in Africa is boldly shifting from merely controlling morbidity to a courageous goal of eliminating infection. Clinical trials revealed effectiveness in delivering sustained reductions in skin microfilarial load, potentially accelerating our journey toward elimination. We envisage that, following the pilot's success, more partners will join to use moxidectin in other parts of the country. The Neglected Tropical Disease Programme is grateful to the Momentum project for their unwavering support.”

“We are extremely pleased that moxidectin will now reach patients in Ghana who need it,” said Professor John Reeder, Director of TDR. “We at TDR will continue to support research that will gather evidence to support the implementation of this new treatment.”

Dr Winnie Mpanju-Shumbusho, Board Chair of Uniting to Combat NTDs, and Former Assistant Director-General for HIV/AIDS, Tuberculosis, Malaria, Neglected Tropical Diseases, World Health Organization said:

“We welcome Ghana’s launch of community-based mass drug administration with moxidectin, a new tool in the fight against onchocerciasis. As one of the first countries to host human clinical trials for moxidectin, Ghana’s leadership underscores the pivotal role disease endemic countries play in advancing research and real-world application of new health technologies. Advances in new treatments, like moxidectin, are critical to accelerating progress towards the eventual elimination of NTDs.”

Walter Panzirer, Trustee of The Leona M. and Harry B. Helmsley Charitable Trust said:

“We are dedicated to supporting MDGH and the Momentum pilot treatment program in Ghana. We are optimistic that this moxidectin pilot treatment will help shape a new, effective approach toward total onchocerciasis elimination in endemic countries around the world.”

Labeeb M. Abboud, Chairman and CEO of The Global Health Investment Corporation (GHIC) said:

“The rollout of moxidectin in Ghana marks an important step forward in efforts to achieve river blindness elimination goals. This achievement is a testament to MDGH’s extraordinary dedication in navigating the complexities of drug development, and in assembling resources and forging strong partnerships to enable access to moxidectin where it is needed most. It also highlights the important role of innovative funding models to advance the development of new health technologies to combat public health challenges that disproportionately affect people living in low- and middle-income countries. For the past decade, GHIC, through our Global Health Investment Fund (GHIF), has been proud to support MDGH and moxidectin, alongside many others who have contributed to its development, and we look forward to the future impact of this important global health medicine.”

Dr John Lambert, General Manager of Atticus Medical said:

“The launch of the Momentum Project is a significant step forward in efforts to eliminate river blindness and improve the lives of millions. At Atticus, we are delighted and proud to have played our part in this journey with MDGH and look forward to catalysing the achievement of more milestones in the future.”

River blindness is a neglected tropical 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. The larvae are transmitted from person to person through the bite of an infected black fly.

Efforts to eliminate river blindness have been under way for several decades, primarily through MDA of ivermectin donated by Merck (known as MSD outside the United States and Canada). The World Health Organization is targeting the elimination of transmission of river blindness and moxidectin represents an important advancement in the treatment options needed to achieve this goal.

Ghana has made significant progress in reducing the prevalence of river blindness, with its efforts cutting transmission across many areas of the country. The Twifo Atti-Morkwa district was identified by the Ghana Health Service as a priority area for moxidectin use after higher-than-expected disease prevalence was detected despite multiple rounds of ivermectin MDA. 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.

MDGH acknowledges the individuals and organisations who have contributed to the development and delivery of moxidectin, especially Ghana Health Service, the Ghanaian and other endemic countries research communities, the people who participated in clinical trials, and the Special Programme for Research and Training in Tropical Disease (TDR). We also wish to extend our thanks to the funders of MDGH who supported the development of moxidectin for river blindness, both leading to and following its 2018 approval by the United States Food and Drug Administration, including the Global Health Investment Fund, Atticus Medical, the European and Developing Countries Clinical Trials Partnership (EDCTP), the Luxembourg National Research Fund, the Gates Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, GiveWell, and Kladne nuly Foundation.

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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 the full United States Prescribing Information 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 Gates Foundation, 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

news@MDGH.com

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