FDA Authorizes Monoclonal Antibodies for Treatment of Covid-19
On February 9, 2021, the FDA issued an EUA to Eli Lilly and Co. for the use of monoclonal antibodies, bamlanivimab and etesvimab, as the treatment of Covid-19. You may remember a similar release from November 2020, where an EUA was issued to Regeneron Pharmaceuticals, Inc. for a different monoclonal antibody treatment involving casirivimab and imdevimab.
“Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.” Both treatments are recommended for patients who have tested positive for SARS-CoV-2 and “who are high risk for progressing to severe COVID-19” but not those who have already been hospitalized or are receiving oxygen therapy. Admission of monoclonal antibodies “may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.”
Regarding Eli Lilly Co.’s treatment, five percent less patients died or were admitted to the hospital during clinical trials. Notably, all the deaths were of patients who were administered the placebo. The clinical trial dose of intravenous bamlanivimab and etesevimab was 2800 milligrams of each, whereas the approved dosage is 700 milligrams of bamlanivimab and 1400 milligrams of etesvimab. These quantities are “based on analyses of available preclinical, clinical, and virologic data, as well as pharmacokinetic and pharmacodynamic modeling,” detailing that the lower dosage will have similar effects. Patient fact sheets will be administered with treatment and will include the following information: dosing instructions, potential side effects, and drug reactions.