In response to the 2019 Novel Coronavirus outbreak, the federal government is taking steps to protect the country. Within the U.S. Department of Health and Human Services, the Office of the Assistant Secretary for Preparedness and Response is working with our partners to explore the development of new medical countermeasures and take other actions to enhance health security.
Monoclonal Antibody Therapeutics
Revocation of FDA’s EUA for Bamlanivimab The FDA has revoked the emergency use authorization (EUA) for bamlanivimab, when administered alone, for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients who are at high risk of disease progression or hospitalization. REGEN-COV as well as bamlanivimab and etesevimab (administered together) continue to be available under EUA.
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The FDA has issued Emergency Use Authorizations for two investigational monoclonal antibody treatments. These treatments have been authorized for patients with mild to moderate cases: those who have had symptoms for 10 days or less, who are 12 years and older, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes people who are 65 years old or older, and who have certain chronic medical conditions. Find out what infusion site professionals patients, and healthcare providers need to know about monoclonal antibody therapeutics.
ASPR's COVID-19 Response by the Numbers
