COVID-19 treatment updates
FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19
FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.
FDA has expanded the approved (PDF) indication for Veklury to include its use in adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
FDA also revised the Emergency Use Authorization (EUA) for Veklury (PDF) to additionally authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. (January 21, 2022)
Health care providers should review this letter (PDF) for important prescribing information.
FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the omicron variant
As we have throughout the COVID-19 pandemic, FDA has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that health care providers on the frontlines have the best tools available to treat patients is a top priority for the agency.
In light of the most recent information and data available, on January 24, 2022, FDA revised the EUAs for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) (PDF) and REGEN-COV (casirivimab and imdevimab) (PDF) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.
Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.
At-home diagnostic test updates
Frequently asked questions
Diagnostic tests can show if you have an active COVID-19 infection and need to take steps to quarantine or isolate yourself from others. Visit our new web page for answers to frequently asked questions related to at-home COVID-19 diagnostic tests, including "Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures?" (Briefly, yes: Bring the test to room temperature for at least 2 hours before using it and check that the test line(s) appear as described in the instructions. Read the full answer.)
FDA authorizes another COVID-19 OTC test based on data from the NIH ITAP
On January 19, 2022, FDA authorized (PDF) another over-the-counter (OTC) COVID-19 antigen test, where validation data were gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The MaximBio ClearDetect COVID-19 Antigen Home Test is an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes.
The test can be used as:
- A single test for people with COVID-19 symptoms.
- A serial test for people without symptoms, meaning the test is done two times over three days.
The test can be used for people:
- Age 14 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
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