Emergency Use Authorization (EUA) for the Treatment of COVID-19
Important facts about bebtelovimab
- Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
- The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
What is COVID-19?
COVID-19 is a disease caused by a type of virus called a coronavirus. Common symptoms include fever, cough, and having trouble breathing.
Some people with COVID-19 have many symptoms, and some have few or no symptoms. And though most people get better within 2 weeks, some people are very sick for a long time — or even die.
There’s no way to know for sure who will get very sick with COVID-19, but some people are at higher risk, including older adults, and people with certain health conditions.
You can find more information about COVID-19 at combatcovid.hhs.gov.
What is bebtelovimab?
Bebtelovimab, pronounced: beb-te-LOV-i-mab
Bebtelovimab is a neutralizing antibody drug. When there’s a virus in your body, like COVID-19, your immune system makes antibodies to fight it off. But it takes time for your body to make antibodies for a new virus — and in the meantime, you could get very sick.
Bebtelovimab contains man made antibodies to help fight the virus. They do not have any COVID-19 virus in them.
Who is this drug for?
Individuals 12 and older who are considered high risk of getting very sick from COVID-19, 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 and may qualify for a monoclonal antibody treatment. Treatment should be administered within 7 days of symptom onset. Talk to your Healthcare Provider for additional information.
Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to:
These are not all the risk factors. Other risk factors can be found on the CDC website.
Please also reference the Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish). Together, you and your healthcare provider can decide if this treatment is an option for you or someone you care for.