FDA Approves New Treatment for Onchocerciasis
The Food and Drug Administration (FDA) has approved moxidectin for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients ≥12 years of age.
Moxidectin, a macrocyclic lactone, is an anthelmintic drug that selectively binds to the parasite's glutamate-gated chloride ion channels. It is active against O. volvulus microfilariae but it does not kill adult O. volvulus parasites. The tropical disease spreads from person to person via black flies that breed near rivers in South and Central America, sub-Saharan Africa and Yemen.
The approval was based on data from two, randomized, double-blind, active-controlled trials in patients with O. volvulus infection (Trial 1: 1472 patients; Trial 2: a dose-ranging trial). Efficacy was assessed by skin microfilarial density from the mean of 4 skin snips per person per time point up to 18 months post-treatment. Treatment with moxidectin was found to be significantly superior to ivermectin (the current standard of care) in suppressing the presence of the microfilariae in skin.
The most common adverse reactions (incidence >10%) in clinical trials included eosinophilia, pruritus, musculoskeletal pain, headache, lymphopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, lymph node pain, dizziness, diarrhea, hyponatremia and peripheral swelling.
Moxidectin was developed through a partnership between the not-for-profit social enterprise Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR). "Achieving FDA approval is a critically important milestone for moxidectin, but our work to bring this medicine to those who need it most continues in earnest," said Mark Sullivan, Founder and Managing Director of MDGH.
Moxidectin is available in 2mg tablets. The safety and efficacy of repeat administration in patients with O. volvulus has not been studied.
For more information visit Medicinesdevelopment.com.