Emergency Use Authorization (EUA) for the Treatment of COVID-19

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Fact Sheet for Patients, Parents and Caregivers (English)

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Fact Sheet for Patients, Parents and Caregivers (Spanish)

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Fact Sheet for Healthcare Providers

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FDA Letter of Authorization

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What you need to know

If you’ve recently been diagnosed with COVID-19, you may have a treatment option: bamlanivimab (bam-la-NIV-i-mab) and etesevimab (e-te-SEV-i-mab), administered together. The research so far shows that for certain people, this treatment option may help limit the amount of virus in the body. This may help their symptoms improve sooner — and they may be less likely to need to go to the hospital. But bamlanivimab and etesevimab administered together is a treatment option that’s still being studied, so there’s a lot that scientists don’t know about the benefits and risks.

Here, you'll learn about COVID-19 and this treatment — including its possible benefits and side effects. Together, you and your healthcare provider can decide if this treatment is an option for you.

Important facts about bamlanivimab and etesevimab

Bamlanivimab and etesevimab are investigational medicines used together to treat mild to moderate symptoms of COVID-19 in adults and adolescents (12 years of age or older who weigh at least 88 pounds [40 kg]), and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization.

• Bamlanivimab and etesevimab have not been approved, but have been authorized for emergency use by the FDA
• Bamlanivimab and etesevimab are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For information on the authorized use of bamlanivimab and etesevimab, and mandatory requirements under the Emergency Use Authorization, please review the Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).

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.

For more information about COVID-19 and when to get tested, refer to our What to know if you have COVID-19 resource and our Patient COVID-19 Testing Education Guide. You can also find more information at combatcovid.hhs.gov.

What are bamlanivimab and etesevimab?

Bamlanivimab and etesevimab are neutralizing antibody drugs. 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.

Bamlanivimab and etesevimab contain man-made antibodies to help fight the virus. They do not have any COVID-19 virus in them.

In a clinical trial, scientists found that people who took bamlanivimab and etesevimab together within 10 days of COVID-19 symptoms starting were less likely to be admitted to the hospital.

• Bamlanivimab and etesevimab have not been approved, but have been authorized for emergency use by the FDA
• Bamlanivimab and etesevimab are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.