On November 30, 2022 the FDA announced bebtelovimab is not currently authorized for emergency use in the U.S. at this time because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.

Bebtelovimab was an investigational medicine used under Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]):

• with positive results of direct SARS-CoV-2 viral testing, and
• who are at high risk for progression to severe COVID-19, including hospitalization or death, and
• for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate.

There is limited information known about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19.

Bebtelovimab was not authorized for use in people who:

• are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDC’s latest information on circulating variants by geographic area), or
• are hospitalized due to COVID-19, or
• require oxygen therapy and/or respiratory support due to COVID-19, or
• require an increase in baseline oxygen flow rate and/or respiratory support due to COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.

What is an Emergency Use Authorization?

The United States FDA had made bebtelovimab available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA has since been revoked on November 30, 2022. The EUA was supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

Bebtelovimab did not undergo the same type of review as an FDA-approved product. When issuing an EUA under the COVID-19 public health emergency, the FDA determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives.

All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA.

Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States.

What is COVID-19?

COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). You can get COVID19 through contact with another person who has the virus. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your or your child’s other medical conditions to become worse. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID-19. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19.

Usual Adult Dose for COVID-19

- 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds.

Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.

Usual Pediatric Dose for COVID-19

- 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds.

Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in pediatric patients (≥12 years of age and weighing at least 40 kg) who are at high risk for progression to severe disease. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.

Before receiving treatment, tell your healthcare provider about all your or your child’s medical conditions including if you or your child:

• Have any allergies
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• Have any serious illnesses
• Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products)

• Allergic reactions. Allergic reactions can happen during and after injection with bebtelovimab. Tell your healthcare provider right away if you or your child develop any of the following signs and symptoms of allergic reaction:
  • fever
  • difficulty breathing
  • low oxygen level 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.

These reactions may be severe or life threatening.

Common side effects include infusion-related reactions, pruritus, and rash.

The side effects of receiving any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site.

These are not all the possible side effects. Not many people have received bebtelovimab. Serious and unexpected side effects may happen. All of the risks are not known at this time.

Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921).

It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bebtelovimab may reduce the body’s immune response to a vaccine for SARS-CoV-2. Talk to your healthcare provider if you have any questions.

Interactions between bebtelovimab and other drugs are unlikely.