Fig 1.
Key milestones in the US FDA’s role to combat NTDs.
Information to create this figure was adapted from FDA websites, FDA databases and approval packages and the Library of Congress Public Laws. FDA, Food and Drug Administration; FD&C, Federal Food, Drug, and Cosmetic; HDE, Humanitarian Device Exemption; NTD, neglected tropical disease; PRV, priority review voucher.
Table 1.
List of diseases or conditions recognized by the WHO and US FDA as NTDs and tropical diseases, respectively.
Fig 2.
Products approved for the tropical disease PRV by the US FDA.
(a) Diseases eligible for the tropical disease PRV program and number of products approved for PRV by FDA, by disease and product type. (b) Products approved, by year, since implementation of the program. Data to generate figure was extracted from FDA approval letters (Drugs@FDA), US SEC filings (EDGAR database using Form 6-K, Form 8-K, and Form 10-K), and US GAO reports. FDA, Food and Drug Administration; GAO, Government Accountability Office; PRV, priority review voucher; SEC, Securities and Exchange Commission.
Fig 3.
Tropical disease products approved under the Orphan Drug Designation Program by the US FDA.
The figure shows products approved by tropical disease, the approved treatment indication, and the market exclusivity period after approval between January 1983 and July 2022. Data was extracted from FDA Orphan Drug Designations and Approvals Database (https://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm). FDA, Food and Drug Administration; HAT, Human African trypanosomiasis.
Table 2.
Number of products and grants approved by FDA as part of the Orphan Products Designation Program and the Orphan Products Grant Program, respectively.
Fig 4.
Overlap between diseases considered as QIDPs by FDA, tropical diseases by FDA, and NTDs by WHO.
Information for this figure was generated using Section 505E(f) of the FD&C Act, Section 524(a)(3) of the FD&C Act and WHO’s list of NTDs. FDA, Food and Drug Administration; FD&C, Federal Food, Drug, and Cosmetic; NTD, neglected tropical disease; QIDP, qualified infectious disease product; WHO, World Health Organization.