FDA Authorizes Another Monoclonal Antibody Treatment
By David Doolittle


Physicians now have another option in the fight against COVID-19, thanks to the U.S. Food and Drug Administration’s (FDA) emergency use authorization (EUA) this week of another monoclonal antibody treatment.

The EUA is for the combination of bamlanivimab and etesevimab, which FDA said reduced hospitalization and death rates of patients with mild to moderate COVID-19 symptoms.

FDA in November approved EAUs for bamlanivimab alone as well as Regeneron’s antibody cocktail of casarivimab and imdevimab. The treatments also have been shown to reduce SARS-CoV-2 virus levels and to decrease risk of hospitalization due to COVID-19, health officials have said

“While bamlanivimab and etesevimab administered together resulted in a lower risk of resistant viruses developing during treatment compared with bamlanivimab administered alone, both treatments are expected to benefit patients at high risk of disease progression,” FDA said.

None of the treatments are authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19, FDA said.

The agency has published fact sheets for both physicians, and patients and caregivers, with details including dosage, preparation, administration, storage, and warnings.

The Centers for Disease Control and Prevention (CDC) recommends that people who have received monoclonal antibody treatments should wait at least 90 days before receiving a COVID-19 vaccine. The 90-day delay should be taken “as a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses,” CDC warned.

In addition, all facilities that administer monoclonal antibody treatments must report specific dosage information, including patient information, through ImmTrac2, the state’s vaccine registry. Facilities must additionally  report the total number of doses administered daily to the Texas Division of Emergency Management.  

Texas created a Therapeutics Finder Map to assist you with locating facilities that can provide the treatments. Physicians must contact the institutions directly to determine availability and to arrange for an infusion. 

Find more tools, resources, and information on TMA’s COVID-19 Resource Center, which is continually updated.

Last Updated On

February 12, 2021

Originally Published On

February 12, 2021

Related Content