19 June 2018 - - Melbourne, Australia-based independent biopharmaceutical company Medicines Development for Global Health (MDGH) and Geneva, Switzerland-based scientific collaborative Special Programme for Research and Training in Tropical Diseases (TDR) have been notified that the US Food and Drug Administration (FDA) has approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older, the agencies said.
River blindness is caused by a parasitic worm, Onchocerca volvulus. The disease manifests as severe itching, disfiguring skin conditions and visual impairment, including permanent blindness, caused by the worm's larvae.
The approval of moxidectin was based on data from two randomized, double blind, active controlled clinical studies. Each study met its respective primary endpoints, showing a statistically significant superiority of moxidectin over the current standard of care, ivermectin, in suppressing the presence of the microfilariae in skin.
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. Moxidectin has activity against O. volvulus microfilariae but does not kill adult O. volvulus parasites.
TDR is a global programme of scientific collaboration that helps facilitate, support and influence efforts to combat diseases of poverty. It is hosted by the World Health Organization and is sponsored by the United Nations Children's Fund, the United Nations Development Programme, the World Bank and WHO.
Non-profit MDGH is dedicated to the development of affordable medicines and vaccines with limited commercial value for neglected diseases prevalent in low and middle income countries.