Bamlanivimab
Bamlanivimab is a monoclonal antibody that recieved emergency use authorization from the US FDA on November 9th, to be used in the treatment of COVID-19.
Emergency use authorization[edit | edit source]
- Bamlanivimab received an emergency use authorization (EuA)by the FDA for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
- Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing
- Are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and
- Are at high risk for progressing to severe COVID-19 and/or hospitalization including those that are 65 years of age or older, or who have certain chronic medical conditions.
[edit | edit source]
Bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
Contra-indications and or cautions[edit | edit source]
- Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
- A benefit of bamlanivimab treatment has not been shown 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.
Monoclonal antibodies[edit | edit source]
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.
Data and clinical studies[edit | edit source]
- The data supporting this EUA for bamlanivimab are based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms.
- Of these patients, 101 received a 700-milligram dose of bamlanivimab, 107 received a 2,800-milligram dose, 101 received a 7,000-milligram dose and 156 received a placebo within three days of obtaining the clinical sample for the first positive SARS-CoV-2 viral test.
- The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo.
- Most patients, including those receiving placebo, cleared the virus by day 11.
Reduced hospitalizations[edit | edit source]
- The most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment.
- For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients.
- The effects on viral load and on reduction in hospitalizations and ER visits, and on safety, were similar in patients receiving any of the three bamlanivimab doses.
When to start[edit | edit source]
It is recommended that bamlanivimab be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.
Dose[edit | edit source]
- Bamlanivimab is administered as a single dose of 700 mg via IV infusion over 60 minutes.
- Bamlanivimab may only be administered in settings in which health care providers would have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS) as necessary.
- Please note that bamlanivimab approved by the FDA to treat COVID-19 and it is an investigational drug.
Summary[edit | edit source]
- It is not currently FDA-approved to treat any diseases or conditions, including COVID-19.
- With the EUA, amlanivimab is authorized for emergency use 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 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Manufacturer[edit | edit source]
Bamlanivimab is manufactured by Eli Lilly and Company.
External links[edit | edit source]
Bamlanivimab Resources | ||
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[edit source]
Coronavirus: WHO declares COVID 19 a pandemic.
Treatments[edit source]
The monoclonal antibodies treatments Bamlanivimab (made by Eli Lilly and Company) and the therapeutic cocktail Casirivimab/Imdevimab (made by Regeneron) called monoclonal antibodies that can be given to help treat patients with COVID-19.
Vaccines[edit source]
List of approved COVID-19 vaccinations in US[edit source]
The following COVID-19 vaccines have received emergency use authorization from the U.S. Food and Drug Administration for the prevention of COVID-19:
- The Pfizer-BioNTech COVID-19 vaccine for use in persons 16 years of age and older.
- The Moderna COVID-19 vaccine for use in persons 18 years of age and older.
- The Johnson & Johnson (Janssen) COVID-19 vaccine for use in persons 18 years and older.
External links[edit source]
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