FDA Declares Chagas Disease, Neurocysticercosis Eligible for Priority Review Voucher
The FDA has added Chagas disease and neurocysticercosis to the list of treatments for tropical diseases eligible for priority review vouchers, bringing the number to 19.
The list can be expanded to include any infectious disease that has no significant market in developed nations and disproportionally affects poor and marginalized populations.
Leaving Chagas disease and neurocysticercosis off the priority review list was an oversight that needed to be corrected, says Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston.
The voucher mechanism will directly benefit the poorest Americans, as well as those living abroad, since an estimated 12 million Americans live with a neglected tropical disease, including the two just added to the list, he said.
Neurocysticercosis is caused by a tapeworm and can lead to epileptic seizures. It affects up to 1.4 million people in Central and South America and up to 4.6 million people in sub-Saharan Africa, according to the FDA.
Chagas disease, a vector-borne parasitic disease, afflicts roughly 9.4 million people, the vast majority living in the Americas.
Read the final order here: www.fdanews.com/8-15-FDA-PRV.pdf. — Jonathon Shacat