NanoViricides (NYSE-A:NNVC) said on Tuesday it has filed an application with the US Food and Drug Administration for Rare Pediatric Disease Drug designation for its antiviral candidate NV-387 as a treatment for measles.
The clinical-stage company said the application, submitted to the FDA’s Office of Orphan Products Development, is expected to be reviewed alongside a separate orphan drug designation request filed in February.
If granted, the designation would make NanoViricides eligible for a Priority Review Voucher upon regulatory approval of NV-387. Such vouchers, which can be sold or transferred, have recently fetched about $160 million and can be used to secure expedited FDA review for another drug.
“There is no approved drug for the treatment of measles at present,” the company said, highlighting the potential unmet need for antiviral therapies alongside existing vaccination programs.
Executive chairman Anil Diwan said NV-387 could become an important tool to combat measles outbreaks in the United States and globally. "Treating a Measles patient with NV-387 would help with rapid recovery and eliminate the high morbidity and the rare post-Measles ‘Immune Amnesia' effects,” he told shareholders.
The rare pediatric disease program, reauthorized by US lawmakers earlier this year, is designed to encourage development of treatments for serious conditions affecting children. Measles qualifies under the program, as the majority of cases occur in individuals under 18.
NanoViricides said NV-387 has shown strong activity against measles infection in animal studies and is designed as a broad-spectrum antiviral using host-mimetic nanomedicine technology. The company added that the candidate has also demonstrated effectiveness in models of other viral infections, including influenza and COVID-19.
"A Rare Pediatric Disease Drug Designation for NV-387 would help us tremendously in the mission of regulatory development and approval of NV-387 to treat Measles, by substantially boosting the potential economic benefits and the business case for this indication," said CFO Meeta Vyas.
The company is working with regulatory consultancy Only Orphans Cote to support its designation applications.