Priority Review Voucher Eligibility List Gains Three Tropical Diseases
US FDA adds brucellosis, opisthorchiasis and paragonimiasis to the list of qualifying diseases but declines to include clonorchiasis and coccidioidomycosis, finding a significant market in developed nations for treatments or vaccines addressing the two conditions.
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The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.
In citizen petition to US FDA, rare diseases nonprofit group asks agency to add sickle cell disease to its tropical disease PRV list since the disease predominantly impacts those who live in Africa and the African American population in the US.
Pneumocystis pneumonia was determined to not meet criteria for a neglected tropical disease that could win sponsors of a new treatment a priority review voucher; FDA made four other diseases eligible.