Emergency Use Authorization (EUA) for the Treatment of COVID-19
What you need to know
If you’ve recently been diagnosed with COVID-19, you may have a new treatment option: bamlanivimab (bam-la-NIV-i-mab). The research so far shows that for certain people, taking this drug 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 is a new drug 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 new treatment — including its possible benefits and side effects. Together, you and your doctor can decide if this treatment is an option for you.
Important facts about bamlanivimab
Bamlanivimab is an investigational medicine used to treat mild to moderate symptoms of COVID-19 in non-hospitalized 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 has not been approved, but has been authorized for emergency use by FDA
- Bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab 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 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.
The only way to know for sure if you have COVID-19 is to get tested. For more information about where and when to get tested, refer to our Patient COVID-19 Testing Education Guide. You can also find more information about COVID-19 at combatcovid.hhs.gov.
What is bamlanivimab?
Bamlanivimab, pronounced: (bam” la niv’ i mab)
Bamlanivimab 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.
Bamlanivimab contains man-made antibodies that are similar to the antibodies of patients who recovered from COVID-19. Scientists think that these antibodies may help limit the amount of virus in your body. This could give your body more time to learn how to make its own antibodies. Bamlanivimab does not have any COVID-19 virus in it.
In a clinical trial, scientists found that bamlanivimab may limit the amount of virus in the body for people with COVID-19 who take the drug within 10 days of symptoms starting. They may also be less likely to need to go to the hospital.
Who is this drug for?
Bamlanivimab is a treatment option for people with COVID-19 who:
- Are age 12 or older
- Have had mild to moderate symptoms for 10 days or less
- Are at high risk to get very sick from COVID-19
- This drug is not for people who are already in the hospital because of their COVID-19 symptoms
For adolescents age 12-17 (weighing at least 88 pounds [40 kg]), bamlanivimab alone may be an option if the child meets at least one of the following criteria:
- Has obesity, with a body mass index (BMI) equal to or greater than 85 percent of children the same age or gender
- Has heart disease
- Has sickle cell disease
- Has a developmental condition, like cerebral palsy
- Has asthma or a long-term lung disease that requires daily medication for control
- Regularly uses medical technology, like a ventilator or feeding tube
For adults, bamlanivimab may be an option if you meet one of the following criteria:
- Are age 65 or older
- Have obesity, with a body mass index (BMI) of 35 or higher
- Have diabetes, chronic kidney disease, or a condition that weakens the immune system
- Take medication that weakens the immune system
Are age 55 or older and have at least one of the following:
- Heart disease
- High blood pressure
- Long-term lung disease
If you’re not sure whether bamlanivimab is right for you, talk with your doctor.