Indication: Indicated for treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients aged 12 years or older.
Mechanism: Moxidectin, a macrocyclic lactone, is an anthelmintic drug. It is closely related to ivermectin, but provides a more sustained reduction in microfilarial levels. The precise mechanism in unknown.
Dosage: 8 mg (four 2-mg tablets) PO as a single dose administered with or without food.
Approval was based on a double-blind, parallel group, superiority trial (N=1472) that compared moxidectin (8 mg PO once) with ivermectin (150 mcg/kg PO once). The trial took place in Ghana, Liberia, and the Democratic Republic of the Congo. Results showed skin microfilarial loads (ie, parasite transmission reservoir) were lower from month 1 to month 18 after moxidectin treatment than after ivermectin treatment, with an 86% difference at month 12. Moxidectin would therefore be expected to reduce parasite transmission between treatment rounds more than ivermectin could, thus accelerating progress towards elimination.
Opoku NO, Bakajika DK, Kanza EM, et al. Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial. Lancet. 2018 Jan 17. pii: S0140-6736(17)32844-1. https://www.ncbi.nlm.nih.gov/pubmed/29361335
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.