Table 1.
Priority review vouchers awarded for tropical diseases
| Year | Disease/product | Manufacturer | Price (US$)a | User/product voucher used for | Comment |
|---|---|---|---|---|---|
| 2009 | Malaria/Coartem® (artemether/lumefantrine) | Novartis | Unsuccessfully used | Novartis/Ilaris® (canakinumab) | The drug was already licensed outside the US |
| 2012 | Tuberculosis/Sirturo® (bedaquiline) | Janssen | Successfully used | Janssen/Tremfya® (guselkumab) | |
| 2014 | Leishmaniasis/Impavido® (miltefosine) | Knight | Sold for $125 million | Gilead/Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide) |
Initially developed through a PDP The drug was already licensed outside the US |
| 2016 | Cholera/Vaxchora® | PaxVax | Sold for $290 million | Gilead/Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) | |
| 2017 | Chagas/Abarax® (benznidazole) | Chemo Research | Unused |
Developed through a PDP New formulation (pediatric) |
|
| 2018 | Onchocerciasis (moxidectin) | Medicines Development for Global Health | Sold for an undisclosed amount | Novo Nordisk/Rybelsus® (semaglutide) | Developed through a PDP |
| 2018 | Malaria/Krintafel™ (tafenoquine) | GlaxoSmithKline (GSK) | Successfully used | GSK/Dovato® (dolutegravir/lamivudine) | Developed through a PDP |
| 2019 | Fasciolasis/Egaten™ (triclabendazole) | Novartis | Succesfully used | Novartis/Kesimpta® (ofatumumab) | The drug was already registered and used outside the US |
| 2019 | Dengue/Dengvaxia® | Sanofi | Unused | ||
| 2019 | Tuberculosis (pretomanid/bedaquiline/linezolid)b | Global Alliance for TB Drug Development | Unused |
Developed through a PDP New formulation combination |
|
| 2019 | Ebola/Ervebo® | Merck | Unused |
PDP product-development partnership
aThe voucher can be unsuccessfully used, which means that it was used to speed up the review of a product (most likely always for market approval) but was rejected by the US FDA. If successfully used, the voucher was used to speed up the review of a product that was approved by the FDA.
bPretomanid tablets in combination with bedaquiline and linezolid is used for the treatment of a specific type of highly treatment-resistant tuberculosis of the lungs. Source: United States Government Accountability Office [4]