Regeneron Pharmaceuticals’ investigational therapy that combines three fully-human monoclonal antibodies, REGN-EB3, is being shipped to the Democratic Republic of the Congo for use in the current Ebola virus infection outbreak. REGN-EB3 is one of several investigational therapeutics evaluated for use by a panel of independent scientific experts convened by the World Health Organization and selected for inclusion in a potential WHO-coordinated clinical trial. A new publication from the Journal of Infectious Diseases describes development of REGN-EB3 and efficacy results at different doses in animal models. In three preclinical studies, REGN-EB3 was seen to treat advanced Ebola virus disease and prevent mortality of infected non-human primates. Regeneron worked with the WHO and FDA to develop an Expanded Access Program protocol to support use of this treatment in the most recent outbreak in the Congo. Regeneron has secured various regulatory approvals, country approvals and import licenses and has hundreds of doses of REGN-EB3 ready to ship beyond the initial shipment currently in process. REGN-EB3 has received orphan drug designation from both the FDA and European Medicines Agency. It is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
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