NanoViricides Files Orphan Drug Application for NV-387 as MPox Treatment

NanoViricides, Inc., a publicly traded company based in Shelton, Connecticut, has announced its application for Orphan Drug Designation (ODD) with the US FDA for NV-387, a treatment aimed at combating the Monkeypox virus (MPox). If approved, NanoViricides could benefit from incentives like tax credits, user fee exemptions, and potential market exclusivity.

Anil R. Diwan, PhD, emphasized the global threat posed by the evolving MPXV virus, underscoring the need for effective therapeutics. NV-387 has shown effectiveness in preclinical models and proven safe in early human trials. Current treatments like Tecovirimat and Brincidofovir have not shown significant clinical success, highlighting a gap in effective MPox treatment.

The ODD application, aided by Only Orphans Cote LLC, positions NanoViricides strategically in the antiviral drug market, aiming to offer innovative solutions against rapidly mutating viral threats.