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Emergency Use Authorizations

FDA Emergency Use Authorizations

Fully FDA Approved

Fully FDA Approved

REGEN-COV

MONOCLONAL ANTIBODY THERAPEUTIC TREATMENT

The monoclonal antibody therapeutics (mAb) continue to be available for ordering and can be used to treat eligible non-hospitalized patients who have tested positive for COVID-19 and have mild to moderate symptoms. These treatments mimic your immune system’s response to SARS-CoV-2 (the infection that causes COVID-19) and are available to eligible patients 12 years and older with a high risk of progressing to severe forms of COVID-19 or being hospitalized. HHS/ASPR has an ample supply of all COVID-19 monoclonal antibody therapeutic products and we are encouraging state and territorial health departments; as well as, healthcare providers to continue ordering and using these products.

Pause in the distribution of bamlanivimab/etesevimab

In June, ASPR has paused all distribution of bamlanivimab/etesevimab together and etesevimab alone on a national basis until further notice. In addition, FDA recommends that health care providers nationwide use alternative authorized monoclonal antibody therapies, REGEN-COV (casirivimab and imdevimab) and sotrovimab, and not use bamlanivimab/etesevimab administered together at this time.

  • REGEN-COV (casirivimab and imdevimab) can be ordered directly from Amerisource Bergen
  • Sotrovimab can be ordered via GlaxoSmithKline’s website: https://www.sotrovimab.com/

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