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September 16, 2021 – The U.S. FDA has expanded the emergency use authorization (EUA) for Eli Lilly's investigation drugs bamlanivimab and etesevimab. These medications can now be administered together to prevent COVID-19 following exposure to the SARS-CoV-2 virus.
- Under the EUA, the drugs can be used for post-exposure prophylaxis (prevention) of COVID-19 in
adults and adolescents (at least 12 years old and weighing at least 40kg, or 88 pounds) who meet
the following criteria:
- Are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated or are not expected to have an adequate immune response to complete COVID-19 vaccination; and
- Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC); or
- Are at high risk of exposure to an individual infected with SARS-CoV-2 because of SARS-CoV-2 infection in other individuals in the same institutional setting, such as a nursing home or prison.
- Are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated or are not expected to have an adequate immune response to complete COVID-19 vaccination; and
- The FDA has emphasized that post-exposure prophylaxis is not a substitute for vaccination against COVID-19.
- Bamlanivimab and etesevimab are also authorized for use together in the treatment of mild to moderate COVID-19 in adults and adolescents (at least 12 years old and weighing at least 40kg) who are at high risk of severe COVID-19, including hospitalization or death.
- The drugs can only be used in states, territories, and U.S. jurisdictions in which the combined frequency of SARS-CoV-2 variants resistant to bamlanivimab and etesevimab does not exceed 5%. The FDA provides a current list of these areas on its website.