Eli Lilly's COVID-19 antibody drug gets FDA emergency approval

The FDA has granted emergency use authorization for Eli Lilly's COVID-19 antibody drug, the agency said Nov. 9 

The drug, called bamlanivimab, is authorized for use in COVID-19 patients with mild to moderate disease. Specifically, the drug is authorized for patients 12 years and older and for populations at high risk of progressing to severe COVID-19 and/or hospitalization. 

The FDA said the drug was shown to reduce COVID-19-related hospitalizations and emergency room visits for high risk patients within 28 days after treatment. 

It's not been authorized for hospitalized patients or those who require oxygen, as monoclonal antibodies such as Eli Lilly's may be associated with worse clinical outcomes in that population. 

Eli Lilly ended its trial of bamlanivimab in hospitalized patients Oct. 26 after an independent safety board found that after five days of treatment, patients receiving the drug showed a different clinical status than the placebo group and the difference crossed a predetermined threshold for safety. The same week, Regenron halted its COVID-19 antibody drug trial in hospitalized patients after an independent t board found a safety concern. 

Monoclonal antibodies are lab-made proteins that mimic the immune systems' ability to fight off harmful antigens such as viruses, the FDA said. Eli Lilly's monoclonal antibody drug is given to patients as a single dose intravenously. 

Read the FDA's full news release here


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