Island Pharmaceuticals received regulatory and ethics approvals to deploy its investigational antiviral Galidesivir for compassionate use in patients affected by the ongoing Bundibugyo Ebola outbreak in Uganda under the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) framework. The program, supported by the Uganda Ministry of Health and conducted with the ACCEPT-Africa Consortium and Makerere University’s Infectious Diseases Institute, is expected to generate prospective human efficacy, safety, and virological data while providing an investigational treatment where no approved therapeutic options currently exist. The program also complements Island’s existing FDA Animal Rule development strategy for Galidesivir and could provide an additional pathway toward potential regulatory approval and future government procurement.
