The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products

The Neglected Tropical Disease Voucher Program is a Congressionally-mandated program intended to promote approval of products for tropical diseases because it provides spectacular financial compensation consequent to FDA approval of a priority product. Three drug approvals–artemether/lumifantrine fo...

Descripción completa

Detalles Bibliográficos
Autores principales: Berman, Jonathan, Radhakrishna, Tanya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The American Society of Tropical Medicine and Hygiene 2017
Materias:
Perspective Pieces
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5239674/
https://www.ncbi.nlm.nih.gov/pubmed/27573627
http://dx.doi.org/10.4269/ajtmh.16-0099
Descripción
Sumario:The Neglected Tropical Disease Voucher Program is a Congressionally-mandated program intended to promote approval of products for tropical diseases because it provides spectacular financial compensation consequent to FDA approval of a priority product. Three drug approvals–artemether/lumifantrine for malaria, bedaquiline for multidrug resistant tuberculosis, miltefosine for leishmaniasis–have received Tropical Disease Vouchers to date. We give our view of the type of products that might qualify for a Tropical Disease Voucher, financial considerations in venturing capital to support product development, clinical ramifications of a successful product approval, and an overall evaluation of the Program.

Ejemplares similares