FDA: Providers should consider whether SARS-CoV-2 variants may resist monoclonal antibody therapies

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FDA: Providers should consider whether SARS-CoV-2 variants may resist monoclonal antibody therapies
tjordan_drupal
Mar 19, 2021

The Food and Drug Administration yesterday updated the health care provider fact sheets for all three monoclonal antibody therapies authorized for emergency use to include information on whether SARS-CoV-2 variants may show resistance to that therapy. According to the updates, prescribing providers should consider whether variants resistant to the therapy are prevalent in their area when considering treatment options. 

The Centers for Disease Control and Prevention has created a federal classification scheme for SARS-CoV-2 variants and posted information on their prevalence in the United States. The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response said it will continue to work with CDC, FDA and the National Institutes of Health on surveillance of variants that may impact the use of monoclonal antibodies and update stakeholders with any new information. Stakeholders also may refer specific questions to COVID19Therapeutics@hhs.gov.

The monoclonal antibody therapies bamlanivimab, etesevimab with bamlanivimab, and casirivimab with imdevimab are authorized for outpatients age 12 or older who have tested positive for COVID-19, had mild to moderate symptoms for 10 or fewer days and are at high-risk for progressing to severe COVID-19. Provider sites can now order etesevimab directly from distributor AmerisourceBergen to pair with existing on-hand doses of bamlanivimab.
 

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FDA: Providers should consider whether SARS-CoV-2 variants may resist monoclonal antibody therapies
tjordan_drupal
Mar 19, 2021

The Food and Drug Administration yesterday updated the health care provider fact sheets for all three monoclonal antibody therapies authorized for emergency use to include information on whether SARS-CoV-2 variants may show resistance to that therapy. According to the updates, prescribing providers should consider whether variants resistant to the therapy are prevalent in their area when considering treatment options. 

The Centers for Disease Control and Prevention has created a federal classification scheme for SARS-CoV-2 variants and posted information on their prevalence in the United States. The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response said it will continue to work with CDC, FDA and the National Institutes of Health on surveillance of variants that may impact the use of monoclonal antibodies and update stakeholders with any new information. Stakeholders also may refer specific questions to COVID19Therapeutics@hhs.gov.

The monoclonal antibody therapies bamlanivimab, etesevimab with bamlanivimab, and casirivimab with imdevimab are authorized for outpatients age 12 or older who have tested positive for COVID-19, had mild to moderate symptoms for 10 or fewer days and are at high-risk for progressing to severe COVID-19. Provider sites can now order etesevimab directly from distributor AmerisourceBergen to pair with existing on-hand doses of bamlanivimab.
 

Novel Coronavirus (SARS-CoV-2/COVID-19)
COVID-19: CDC, FDA and CMS Guidance
COVID-19: Vaccines and Therapeutics

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