NanoViricides announced that the European Medicines Agency has awarded orphan drug designation to DengueCide, the company’s drug candidate for the treatment of dengue and dengue hemorrhagic fever. This orphan drug designation enables several benefits for the company’s dengue drug development program. These benefits include “protocol assistance,” or specific scientific advice that can speed up the drug development program, as well as certain fee reductions, for drug approval(s) under EMA. An approved orphan medicine in the EMA countries is expected to benefit from ten years of marketing exclusivity protection. An additional two years of exclusivity can be obtained if the drug development has complied with an agreed pediatric investigation plan, with a total of twelve years of market exclusivity for a drug that is approved for both adult and pediatric usage.
- Health Care Industry
- Pharmaceuticals & Drug Trials
- orphan drug designation
- European Medicines Agency