NanoViricides says NV-387 could address measles outbreaks as cases rise globally
NanoViricides’ Measles Treatment Granted Orphan Drug Designation by FDA
NanoViricides, Inc. said the FDA granted “Orphan Drug Designation” (ODD) to its clinical-stage, antiviral drug NV-387 for the treatment of measles, giving the company seven years of market exclusivity after approval and access to tax credits, among other benefits.There is no approved drug to treat the disease and NV-387 is the only known treatment with a strong in vivo activity against lethal infection with the Measles virus, the company said.
Measles is highly contagious and more than 95% of the population should be vaccinated to block the disease from spreading if a case occurs.The company stated it also applied for the “Rare Pediatric Disease Drug” (RPDD) designation, which if granted would give NanoViricides a “Priority Review Voucher,” reducing the FDA review time significantly.This voucher is tradable and has obtained $150 to $200 million when the holder trades it, becoming an early revenue resource.
Global cases have increased in recent years due in part to vaccine hesitancy, the company stated.Growing cases in the Western world include the U.S. and Canada, as well as several European countries and the U.K.. Mexico and multiple Central and South American countries are also experiencing rising Measles outbreaks, the company stated.Many countries that had previously achieved an elimination status have lost it nowadays due to considerable outbreaks in the last three years.
Measles is a rare disease in the U.S. with annual incidence rates below 200,000 cases, which qualified NV-387 as a treatment for measles under the Orphan Drug indication, NanoViricides said.“NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved,” said Anil R. Diwan, PhD., NanoViricides President and Executive Chairman.
