Regeneron’s Ebola Antibody Recommended by World Health Organization for Investigational Use in Response to Current Bundibugyo Ebolavirus Outbreak

The World Health Organization’s Therapeutics Advisory Group has recommended Regeneron’s antibody maftivimab for evaluation in clinical trials as a potential monotherapy for the ongoing Bundibugyo ebolavirus outbreak in the Democratic Republic of the Congo and Uganda. The recommendation follows WHO’s declaration that the outbreak constitutes a public health emergency of international concern. Maftivimab, the most potent neutralizing antibody in Regeneron’s Inmazeb—approved by the U.S. Food and Drug Administration for Zaire ebolavirus—has demonstrated broad *in vitro* activity against multiple Ebola species, including Bundibugyo, though it has not yet been tested *in vivo* as a standalone treatment for this strain. Regeneron’s Inmazeb, a three-antibody cocktail, was the first FDA-approved Ebola treatment and has been administered to hundreds of patients since 2018. The company has provided Inmazeb at no cost under compassionate use protocols during previous Zaire ebolavirus outbreaks in the DRC and Guinea. Maftivimab, a key component of Inmazeb, has been administered to hundreds of patients as part of the combination therapy, which has shown an acceptable safety profile. The WHO is now coordinating with the governments of the DRC and Uganda to facilitate clinical trials of prioritized treatments, including maftivimab. Regeneron has pledged to collaborate with global health organizations and local authorities to accelerate the evaluation process. The company has a history of rapid response in global health crises, including during the COVID-19 pandemic and previous Ebola outbreaks. Inmazeb remains approved for Zaire ebolavirus infections in adults and children, including neonates born to infected mothers. Regeneron has previously donated 500 doses of Inmazeb to support outbreak response efforts. The company’s leadership emphasized its commitment to advancing innovative treatments during urgent public health emergencies, highlighting the importance of independently run, locally executed clinical trials for developing effective medicines.