On February 11, 2022, the U.S Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bebtelovimab, a new monoclonal antibody treatment for COVID-19 in adults and children 12 years and older. As the number of infected cases increases daily, the authorization for bebtelovimab comes as great news since the FDA ceased the use of two other monoclonal antibody treatments as of January 22, 2022. Data has shown that the other two treatments—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab)—are unlikely to be effective against the COVID-19 omicron variant.

What you need to know about bebtelovimab:

It is a monoclonal antibody therapy that is effective against the omicron variant.
Like other monoclonal antibodies, bebtelovimab are lab-made proteins that mimic the immune system’s ability to fight harmful pathogens such as the coronavirus.
Bebtelovimab looks for and attaches to the spike protein shape of the virus that causes COVID-19. Once bebtelovimab binds to the spike protein, it blocks the virus' ability to enter cells, thus, slowing down the infection.
Bebtelovimab has been tested in low-risk and high-risk patients in a clinical trial.
Bebtelovimab is made by Eli Lilly; the department of Health and Human Services had purchased 600,000 doses with the goal to get all of the treatment courses by March of this year.
Bebtelovimab is given as an intravenous injection (IV or through a vein) over at least 30 seconds. A healthcare provider then monitors the patient for at least one hour after administering bebtelovimab.
The possible side effects of bebtelovimab include itching, rash, infusion-related reactions, nausea, and vomiting.

What are the criteria for receiving bebtelovimab?

Bebtelovimab is authorized to treat mild-to-moderate COVID-19 in adults and children 12 years and older, weighing at least 88 pounds (40 kg) who meet all of the following criteria:

Having a positive COVID-19 test
Being at high risk for progression to severe COVID-19, including hospitalization and death
There are no available alternative treatments that are appropriate.

Who are not candidates to receive bebtelovimab?

Hospitalized patients
Those who require oxygen therapy or other respiratory support due to COVID-19
Those who are already on long-term oxygen therapy due to other illnesses and now require an increase in oxygen flow rate due to COVID-19.
Those who are infected with other COVID-19 variants that are not able to be treated by bebtelovimab.

What is Emergency Use Authorization (EUA)?

The U.S. FDA can issue EUAs as tools to treat patients during a public health emergency, such as the COVID-19 pandemic.

As the regular FDA-approving process can take years, EUA makes certain medical products available quickly to prevent and treat serious or even life-threatening diseases when there are no adequate, approved, and available options.

EUAs are effective until the emergency declaration ends. At any time, EUAs can be revised or revoked by the FDA based on data and patient needs during a public health emergency.

Should you be worried since these medical products are unapproved?

Before issuing EUA, these medical products must meet specific FDA criteria to prove their safety and efficacy. The FDA carefully evaluates the risks and the benefits of these products based on available data. An EUA is only issued when the benefits outweigh the risks.

What to tell your healthcare providers before receiving bebtelovimab?

If you or your child have any allergies
If you are pregnant or plan to become pregnant
If you are breastfeeding or plan to breastfeed
If you or your child have any serious health conditions
Provide your healthcare providers with a list of all the medicines you or your child are taking, including prescription, over-the-counter products, vitamins, and herbal supplements.

Severe or life-threatening allergic reactions can also happen during and after the bebtelovimab injection. You should inform your healthcare provider right away if you or your child experience any of the following signs and symptoms: fever, difficulty breathing, low oxygen levels in your blood, chills, tiredness, fast or slow heart rate, chest discomfort or pain, weakness, confusion, nausea, headache, shortness of breath, low or high blood pressure, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, dizziness, feeling faint, and sweating.

References:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-monoclonal-antibody-treatment-covid-19-retains

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron

https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs