MDGH & TDR partnership awarded US FDA's approval for moxidectin for the treatment of river blindness.
M2 PHARMA-June 14, 2018-MDGH & TDR partnership awarded US FDA's approval for moxidectin for the treatment of river blindness
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Biopharmaceutical company Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) reported on Wednesday the receipt of approval for moxidectin in 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older under the US FDA's priority review voucher (PRV) tropical disease programme.
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 (microfilariae).
TDR (the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases) was instrumental in the development of moxidectin, 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.
This US FDA's approval of moxidectin was based on data from the company's two randomised, double blind, active controlled clinical studies. Each study met its primary endpoints, showing a statistically significant superiority of moxidectin over the current standard of care in suppressing the microfilariae in skin.
The PRV reportedly permits the holder to accelerate the review of a new drug application (NDA) from the standard 10 months to six months.
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|Date:||Jun 14, 2018|
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