Island Pharma Closes In On FDA Feedback For Potential Ebola And Marburg Treatment
Island Pharmaceuticals is advancing its broad-spectrum antiviral drug Galidesivir, originally developed with U.S. government support, toward regulatory approval for ultra-lethal viruses such as Marburg virus disease and Ebola virus disease. The company is engaging with the U.S. Food & Drug Administration (FDA) to determine whether the program can qualify under the so-called “Animal Rule”—which allows approval based on well-controlled animal studies when human trials are neither ethical nor feasible. They are also seeking clarity on eligibility for a Priority Review Voucher (PRV), which could significantly accelerate commercialization or be monetized later. Island expects to receive the FDA’s feedback imminently and sees the potential for significant commercial upside if Galidesivir is approved for filovirus outbreak counter-measures. 
Island Pharma Closes In On FDA Feedback For Potential Ebola And Marburg Treatment