Priority review voucher news

August 25, 2015

The PRV program was initially adopted by the FDA in 2007 to incentivise the development of drugs to treat neglected tropical diseases (NTDs) (see list below), which would ordinarily attract little, if any, pharmaceutical development interest.

Under the scheme, companies with any newly approved drug intended to treat a designated NTD become eligible to receive a Tropical Disease Priority Review Voucher. In 2012, the program was expanded to cover rare pediatric diseases, with the creation of Rare Pediatric Disease Priority Review Vouchers awarded upon registration of therapies targeting diseases affecting fewer than 200,000 children in the US. To date, six priority review vouchers, three of each type, have been awarded by the FDA to be redeemed by the recipient or sold on to another company.

The list of eligible NTDs (see list below) was recently expanded with the addition of Chagas disease, a trypanosomal disease affecting approximately 8 million people in South and Central America, and Neurocysticercosis, a disease associated with high rates of epilepsy in South America and Africa caused by tapeworm infection.

Target disease for PRV-eligible tropical disease product applications

Added August 2015

  • Chagas disease
  • Neurocysticercosis

Added December 2014

  • Filoviruses (including Ebola and Marburg viruses)
  • Blinding trachoma
  • Buruli Ulcer
  • Cholera
  • Dengue/dengue haemorrhagic fever
  • Dracunculiasis
  • Fascioliasis
  • Human African Trypanosomiasis
  • Leishmaniasis
  • Leprosy
  • Lymphatic filariasis
  • Malaria
  • Onchocerciasis
  • Schistosomiasis
  • Soil-transmitted helminthiasis
  • Tuberculosis
  • Yaws

Source: Regulatory Affairs Professional Society and FDA