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FDA issues EUA for bamlanivimab IV for COVID-19 outpatients

06 Dec 2020

Accepting orders to SH COVID outpatient infusion (formerly Parkside Clinic on 12th St.) next week.

By: Joshua Free, PharmD, chief pharmacy officer and Jasmin Chaudhary, MD, infectious disease specialist

The U.S. Food and Drug Administration issued two emergency use authorizations to permit treatment with monoclonal antibodies for IV infusion in non-hospitalized COVID-19 patients. Bamlanivimab by Eli Lilly and a combination product casirivimab + imdevimab by Regeneron, are both under EUA for COVID-positive patients meeting specific high-risk criteria, but not requiring inpatient care.

Early results from the BLAZE-1 trial showed that among patients who were at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients compared to 10% in placebo-treated patients.  The ongoing trial for casirivimab + imdevimab is structured differently, but demonstrated similar results (3% versus 9%, respectively).

Based on scientific evidence available, the FDA determined both bamlanivimab and casirivimab + imdevimab may be effective for some high-risk patients.  Both drugs are only for non-hospitalized COVID-positive patients at least 12 years old weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. 

We are currently securing a supply from the State of Oregon and making plans to accept orders to SH COVID outpatient infusion (formerly Parkside Clinic on 12th St.) next week. There will be limited supply and limited staffing, however we are making plans to accommodate as many patients as possible.

FDA FAQ documents:       Bamlanivimab                    casirivimab + imdevimab

FDA fact sheets:              Bamlanivimab                    casirivimab + imdevimab

EUA information:             Bamlanivimab                    casirivimab + imdevimab

If you have questions, please email Joshua Free.