NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company developing broad-spectrum antivirals, announced it has filed an application with the U.S. FDA for Rare Pediatric Disease Drug designation for NV-387 as a treatment for measles. The application follows a previously submitted orphan drug designation filing and could make the company eligible for a Priority Review Voucher upon approval. This supports regulatory advancement of NV-387 as a potential treatment in a market where no approved measles therapies currently exist.
Measles remains a significant global health concern, with outbreaks occurring even in developed countries due to vaccine hesitancy. The World Health Organization reported over 9 million cases and 128,000 deaths in 2021 alone. Currently, no specific antiviral treatment is approved for measles; management is supportive. If NV-387 obtains FDA approval, it would be the first antiviral specifically indicated for measles, potentially filling a critical gap.
NV-387 is a broad-spectrum antiviral drug that has shown efficacy in animal models against measles, as well as other viruses including RSV, COVID-19, influenza, monkeypox, and smallpox. The drug has completed a Phase I human clinical trial in healthy volunteers with no reported adverse events. NanoViricides is focused on advancing NV-387 into Phase II human clinical trials.
The Rare Pediatric Disease designation is intended to encourage development of treatments for serious or life-threatening diseases affecting fewer than 200,000 people in the U.S. under age 18. If a drug receives approval, the sponsor may qualify for a Priority Review Voucher (PRV), which can be used to expedite review of a subsequent drug application or sold to another company. PRVs have historically sold for between $100 million and $350 million, providing significant financial incentive.
NanoViricides also has other drug candidates, including NV-HHV-1 for herpesvirus infections. The company notes that it cannot project an exact date for filing an IND for any of its drugs due to dependence on external collaborators and consultants. More information about NanoViricides and its pipeline is available on its website at https://www.nanoviricides.com.
The full press release can be viewed at https://ibn.fm/h9IB4. For the latest news and updates on NanoViricides, visit the company's newsroom at https://ibn.fm/NNVC.
