The FDA has issued an Emergency Use Authorization (EUA) for use of ACTEMRA for coronavirus disease 2019 (COVID-19) in adult and pediatric patients
Which patients are authorized to receive ACTEMRA?
ACTEMRA is a prescription medication that may benefit certain adults and children (2 years of age and older) in the hospital with COVID-19 who are receiving corticosteroids and who require supplemental oxygen, or a machine that helps with their breathing (ventilator) or a machine that adds oxygen to the blood outside the body (extracorporeal membrane oxygenation or ECMO). There is limited information known about the safety or effectiveness of using ACTEMRA to treat people in the hospital with COVID-19. Available results from clinical trials in adults indicate that treatment with ACTEMRA may decrease the risk of dying in hospitalized patients with COVID-19 who are receiving corticosteroids and who require supplemental oxygen, or a ventilator or ECMO. The safety and effectiveness of ACTEMRA have not been studied in children hospitalized with COVID-19. ACTEMRA is not FDA-approved to treat COVID-19.
The EUA for ACTEMRA is in effect for the duration of the COVID-19
declaration justifying emergency use of this product, unless
terminated or revoked (after which the products may no longer be
used under the EUA).
What is an Emergency Use Authorization?
The United States FDA has made ACTEMRA available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is 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.
ACTEMRA as a treatment for COVID-19 has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA must determine, among other things, that based on the totality of scientific evidence available, 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 medicine to be used in the treatment of patients during the COVID-19 pandemic.
What is COVID-19?
COVID-19 is caused by a virus called a coronavirus. You or your child can get COVID-19 through close 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, long lasting (chronic) medical conditions like heart disease, lung disease and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.
What are the symptoms of COVID-19?
The symptoms of COVID-19 are fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure. Serious illness, including breathing problems, can occur and may cause your or your child's other medical conditions to become worse.
Download the EUA Fact Sheet
This Fact Sheet contains information to help patients, parents and caregivers understand the potential risks and benefits of taking ACTEMRA.
How can I learn more about COVID-19?
- Ask your or your child's healthcare provider
- Visit https://www.cdc.gov/COVID19
- Contact your local or state public health department