U.S. FDA expands indication for moxidectin to treat river blindness in children as young as four

Melbourne, Australia

Medicines Development for Global Health (MDGH) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for moxidectin 2mg tablets for the treatment of river blindness (onchocerciasis) in children aged four years and older and weighing at least 13 kg.¹

Moxidectin was approved by the U.S. FDA in 2018 for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older.

Sarah Kilpatrick, Associate Director, Global Regulatory Affairs: “MDGH welcomes the U.S. FDA approval to expand the indication of moxidectin 2 mg tablets for the treatment of onchocerciasis in children. This milestone reinforces our commitment to advancing the global fight against river blindness.”

The sNDA is based on results from a paediatric dose-finding study which completed in 2022 and informed the selection of a dose for children aged 4 to 11 years (Study MDGH‑MOX‑1006). This Phase 1 open-label study evaluated the pharmacokinetics (PK) and safety of a single moxidectin dose in participants aged 4 to 17 years with, or at risk of, onchocerciasis. Data from this study, along with associated modelling and simulation, enabled the extrapolation of efficacy data from adults and adolescents to children aged 4 to 11 years.

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