Seems like there are some vaccine similarities as far a emergency Use Authorization....and Budesonide is pretty much a first line treatment here...
REGEN-COV™ (casirivimab and imdevimab) eligibility and access sites
Treatment:
The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for REGEN-COV™ (casirivimab and imdevimab) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Limitations of Authorized Use (Treatment)
REGEN-COV is not authorized for use in patients:
who are hospitalized due to COVID-19, OR
who require oxygen therapy due to COVID-19, OR
who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation
Post-Exposure Prophylaxis:
REGEN-COV is authorized in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or
who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)
Limitations of Authorized Use (Post-Exposure Prophylaxis)
Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19
REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19
REGEN-COV has not been approved but has been authorized for emergency use by the FDA. These uses are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized uses of REGEN-COV.
