Early development The 2014 Ebola outbreak killed more than 11,300 people. In the Democratic Republic of Congo (DRC), as of January 2020, this is the second largest outbreak with over 3,400 confirmed or probable cases, including more than 2,200 deaths. Regeneron used its VelociGene, VelocImmune, and VelociMab antibody discovery and production technologies and coordinated with the U.S. government's
Biomedical Advanced Research and Development Authority (BARDA). The therapy was developed in 6 months and a Phase 1 trial in healthy humans was completed in 2015. Approximately 1 month following the conclusion of the Équateur province outbreak, a distinct outbreak was noted in
Kivu in the DRC (
2018–20 Kivu Ebola outbreak). Once again, mAb114 received approval for compassionate use by WHO MEURI and DRC ethic boards and was given to many patients under these protocols. The survival rate if the drug was administered shortly after the infection was 89%. In August 2019, Congolese health officials announced it was more effective compared to two other treatments being used at the time.
Regulatory status The FDA granted the application for REGN-EB3 (atoltivimab/maftivimab/odesivimab) as
orphan drug and
breakthrough therapy designations. == References ==