NanoViricides, a clinical-stage biotechnology company developing broad-spectrum antivirals, said on Tuesday it has filed an application with the US Food and Drug Administration (FDA) for Orphan Drug Designation (ODD) for its experimental drug NV-387 as a treatment for measles.
If granted, the designation would provide the company with significant incentives, including tax credits for qualified clinical trials, exemptions from certain FDA user fees, and potential seven-year market exclusivity following approval.
The urgency for new treatments is underscored by recent data. Measles cases in the United States have surged, with 2,251 confirmed cases and three deaths reported in 2025, a stark increase from 285 cases in 2024 and only 59 in 2023.
Currently, there is no approved drug treatment for measles. While vaccination remains the primary preventive measure, full immunity requires two doses spaced apart, leaving gaps in protection during outbreaks.
NV-387 is described as a broad-spectrum antiviral that has shown strong in vivo activity against lethal measles infection in humanized animal models. Beyond measles, the drug has demonstrated efficacy against other viral threats, including respiratory syncytial virus (RSV), COVID-19, influenza, and Mpox.
To support the ODD application, the company engaged regulatory consultant Only Orphans Cote, LLC, founded by Dr. Timothy Cote, the former director of the FDA’s Office of Orphan Products Development.
