NanoViricides announces progress in Europe on review of dengue drug candidate
EMA's Committee on Orphan Medicinal Products appointed the team to review NanoViricides' upcoming orphan drug designation application for DengueCide. NanoViricides recently submitted a letter of intent to file the application with the EMA. NanoViricides plans to file the application after the appropriate notification period of 60 days and following the translation of the application into 27 different languages.
DengueCide is a nanoviricide that showed very high effectiveness in a dengue animal study. Dengue hemorrhagic fever, which is associated with a high fatality rate in humans, typically kills 100 percent of untreated mice. In the DengueCide study, animals treated with the drug candidate achieved an unprecedented 50 percent survival rate.
There is no currently approved effective drug treatment or vaccine for dengue virus infection. The mosquito-borne illness causes approximately 400 million cases of dengue fever, more than one million cases of dengue hemorrhagic fever and 50,000 to 100,000 deaths annually around the world.
If an orphan designation is granted for DengueCide, NanoViricides may be able to assign a higher priority to its dengue drug program and undertake rapid development.