Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor-binding domain of the spike protein of SARS-CoV-2. The FDA has authorized the emergency use of bamlanivimab for the treatment of COVID-19 under an Emergency
Use Authorization (EUA).
" Based on review of the topline data from the planned interim analysis of Trial J2W-MC-PYAB, also called BLAZE-1 (NCT04427501), an ongoing randomized, double-blind, placebocontrolled, Phase 2 dose finding trial of bamlanivimab monotherapy in outpatients with mild to moderate COVID-19, it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab outweigh the known and potential risks of such product." -FDA
Criteria for Issuance of Authorization
" Based on review of the topline data from the planned interim analysis of Trial J2W-MC-PYAB, also called BLAZE-1 (NCT04427501), an ongoing randomized, double-blind, placebocontrolled, Phase 2 dose finding trial of bamlanivimab monotherapy in outpatients with mild to moderate COVID-19, it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab outweigh the known and potential risks of such product." -FDA
Criteria for Issuance of Authorization
- SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
- Based on the totality of scientific evidence available to FDA, it is reasonable to believe that bamlanivimab may be effective in treating mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab outweigh the known and potential risks of such product; and. There is no adequate, approved, and available alternative to the emergency use of bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
LIMITATIONS OF AUTHORIZED USE
Bamlanivimab is not authorized for use in patients:
- who are hospitalized due to COVID-19,
- who require oxygen therapy due to COVID-19,
- who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
- Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
DOSAGE
The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older
weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over
at least 60 minutes. Bamlanivimab should be given as soon as possible after positive
results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.
ADVERSE EVENTS
- Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
- There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy.
- Infusion-related reactions have been observed with administration of bamlanivimab. Signs and symptoms of infusion related reactions may include: fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
For more visit
http://pi.lilly.com/eua/bamlanivimab-eua-factsheet-hcp.pdf
https://www.fda.gov/media/143602/download
