Table 1. Sample of novel neglected disease products presented to regulators since 2005 [8],[11],[12],[20]–[23].
Novel Neglected Disease Products | Regulatory Stage |
Artesunate-amodiaquine ASAQ (malaria) | Approved by 24 African countries |
WHO prequalified (October 2008) | |
Artesunate-mefloquine ASMQ (malaria) | Approved by Brazilian ANVISA (April 2008) |
Coartem Dispersible (malaria) | Approved by 14 African countries |
Approved by Swissmedic (December 2008) | |
WHO prequalified (February 2009) | |
Intramuscular paromomycin (visceral leishmaniasis) | Received FDA and EMA orphan drug designation (March 2005) |
Approved by Drugs Controller General of India (August 2006) | |
Eurartesim (malaria) | Submitted to EMA for approval (July 2009) |
Moxifloxacin (TB) | Clinical development plan submitted to developing country and/or Western regulators |
PA-824 (TB) | Clinical development plan submitted to developing country and/or Western regulators |
Arterolane/PQP (malaria) | Clinical development plan submitted to developing country and/or Western regulators |
Azithromycin-chloroquine AZCQ (malaria) | Clinical development plan submitted to developing country and/or Western regulators |
Fexinidazole (sleeping sickness) | Clinical development plan submitted to developing country and/or Western regulators |
Additional source: correspondence with Novartis.