NanoViricides has secured orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue hemorrhagic fever.
Dengue fever is a mosquito-borne disease that affects around 400 million people per annum, while dengue hemorrhagic fever is a subset of the disease that can occur after reinfection with another strain of the same virus, has a case fatality rate of about 20%, according to the World Health Organization (WHO).
The orphan drug designation will provide several benefits including 'protocol assistance', or specific scientific advice that can accelerate its drug development programme, as well as certain fee reductions, for drug approval under EMA.
The company said, an approved orphan medicine in the EMA countries is expected to benefit from ten years of marketing exclusivity protection.
In addition, two years of exclusivity can also be secured if the drug development has complied with an agreed pediatric investigation plan, with a total of 12 years of market exclusivity for a drug that is approved for both adult and pediatric usage.
Earlier the company has also received orphan drug designation from the US FDA for DengueCide.
Recently, the company had renewed its evaluation agreement for DengueCide and next generation dengue therapeutics with the Eva Harris Laboratory at the University of California, Berkeley.
Currently, DengueCide is in pre-clinical development and if successful, the company will need to file an Investigational New Drug (IND) application to the US FDA and carry out human clinical trials.
After successful human clinical trials, the company has to file a NDA to the FDA to obtain approval to market the drug.