FDA New Drug and Biologic Approvals, 2018 Midyear Review

Onchocerciasis: Moxidectin

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.

Reference:

• 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.