NanoViricides, Inc. (NYSE American: NNVC) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its clinical-stage antiviral drug NV-387 for the treatment of measles. This designation provides potential incentives, including tax credits, fee exemptions, and market exclusivity, which are intended to support the regulatory advancement of the drug candidate. The company highlighted that NV-387 has demonstrated in vivo activity against measles and is being developed to address increasing global outbreaks.
Orphan Drug Designation is granted by the FDA to drugs intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. The designation qualifies NanoViricides for various development incentives, such as tax credits for clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity upon approval. This regulatory milestone underscores the potential of NV-387 to address unmet medical needs in the treatment of measles, a disease that has seen a resurgence in recent years due to declining vaccination rates.
NV-387 is a broad-spectrum antiviral drug candidate that has shown effectiveness in animal models against multiple viruses, including measles, monkeypox (MPox), smallpox, and respiratory viruses. The drug has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events. NanoViricides is currently focused on advancing NV-387 into Phase II human clinical trials for the treatment of respiratory syncytial virus (RSV), COVID-19, influenza, and other respiratory viral infections.
The company's pipeline also includes NV-HHV-1 for the treatment of herpesvirus infections, including HSV-1, HSV-2, VZV shingles, and chickenpox. However, NanoViricides noted that it cannot project an exact date for filing an Investigational New Drug (IND) application for any of its drugs due to dependence on external collaborators and consultants.
For more information, visit the company's website at https://www.nanoviricides.com and view the full press release at https://ibn.fm/uIWWv.
