Infectious Disease

The Fed stops distributing Eli Lilly’s bamlanivimab for COVID-19 alone

March 26, 2021

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The U.S. government, working with Eli Lilly, said it has stopped distributing the drug maker’s monoclonal antibody bamlanivimab solely for the treatment of COVID-19 due to concerns about emerging SARS-CoV-2 variants.

HHS announced the update online, saying the government stopped distributing the therapy alone on March 24, due to the number of SARS-CoV-2 virus variants resistant to bamlanivimab given alone and the availability of others in the US Approved Monoclonal Drugs ‚ÄúThere has been a sustained increase in antibody therapies that are expected to maintain the activity of these variants. “

Rajesh T. Gandhi

In an update to its health care provider fact sheet on bamlanivimab, the FDA said that using other monoclonal antibody therapies that are more likely to maintain activity against the variants may reduce the possibility of treatment failure due to an infection that is only resistant to bamlanivimab .

The FDA also determined that bamlanivumab is not approved for the following patients:

  • Patients Admitted to Hospital Due to COVID-19;
  • Patients with COVID-19 who need oxygen therapy; and
  • Patients who require an increased baseline oxygenation rate due to COVID-19 in individuals on chronic oxygen therapy caused by an underlying comorbidity.

The FDA issued emergency approval for bamlanivimab in November for mild to moderate COVID-19 in adults and children.

The Infectious Disease Society of America suggests using bamlanivimab along with the monoclonal antibody etesevimab in outpatients with mild to moderate COVID-19 who are at high risk of severe disease progression. During an IDSA briefing last week Rajesh T. Gandhi, MD, A member of IDSA’s Panel of Experts on COVID-19 Treatment and Management Guidelines and an Infectious Disease Doctor at Massachusetts General Hospital noted that data are limited on using bamlanivimab alone to treat COVID-19.

HHS said treatment dispensaries would still be able to order bamlanivimab and eesevimab co-administered.

References:

FDA. Healthcare Provider Fact Sheet: Emergency Authorization for Bamlanivimab. https://www.fda.gov/media/143603/download. Accessed March 26, 2021.

Press release

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