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Posted On: 11/22/2020 3:59:01 AM
Post# of 149490
Further important quote from the corresponding FDA letter (meaning that this EUA poses no hindering for a possible Leronlimab approval):
"Casirivimab and imdevimab is not authorized for use in the following patient
populations (5):
• Adults or pediatric patients who are hospitalized due to COVID-19, or
• Adults or pediatric patients who require oxygen therapy due to COVID-
19, or
• Adults or pediatric patients who require an increase in baseline oxygen
flow rate due to COVID-19 in those patients on chronic oxygen therapy
due to underlying non-COVID-19-related comorbidity.
(5): Benefit of treatment with casirivimab and imdevimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation."
https://www.fda.gov/media/143891/download
"Casirivimab and imdevimab is not authorized for use in the following patient
populations (5):
• Adults or pediatric patients who are hospitalized due to COVID-19, or
• Adults or pediatric patients who require oxygen therapy due to COVID-
19, or
• Adults or pediatric patients who require an increase in baseline oxygen
flow rate due to COVID-19 in those patients on chronic oxygen therapy
due to underlying non-COVID-19-related comorbidity.
(5): Benefit of treatment with casirivimab and imdevimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation."
https://www.fda.gov/media/143891/download
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