After getting orphan-drug status in August from the U.S. Food & Drug Administration for its dengue drug candidate, West Haven’s NanoViricides has achieved the same status in Europe, it announced.
Orphan status gives NanoViricides 10 years of marketing exclusivity in Europe. It could speed up Denguicide’s development program and also offers reduced fees for drug approval in Europe, the company said.
In the U.S., orphan status provides tax credits, fee waivers and accelerated regulatory review.
