Regeneron’s antibody cocktail REGN-EB3 (Inmazeb) first FDA-approved treatment for Ebola (Zaire Ebolavirus)

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On Oct. 14, 2020, Regeneron announced that the U.S. Food and Drug Administration (FDA) had approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

As part of an agreement announced in July 2020, Regeneron will deliver an established number of Inmazeb treatment doses over the course of six years to the Biomedical Advanced Research and Development Authority (BARDA), as part of the U.S. Department of Health and Human Services’ (HHS) goal of building national preparedness for public health emergencies.

In keeping with our mission and values, Regeneron is committed to making this important medicine available to the people who need it. In response to the 2018 Ebola outbreak in the Democratic Republic of the Congo (DRC), we worked with the World Health Organization (WHO), U.S. FDA and other global organizations to offer Inmazeb under a compassionate use protocol and include it in the four-arm PALM (PAmoja TuLinde Maisha) Trial. With BARDA support, we continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use. Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries.

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Source: Regeneron
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