The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is a product of Eli Lilly & Company. This is the first treatment for COVID-19 approved for use by the FDA.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.
It is similar to, but not identical to, the monoclonal antibody regimen under development by Regeneron, which got to be known when Pres. Donald Trump was given it when he had COVID-19.
The FDA says studies are continuing, but that bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
Bamlanivimab is authorized for patients with COVID-19 who are 12 years of age or older, weigh at least 88 pounds, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.
Eli Lilly said in a news release that it will ship supplies of bamlanivimab to a distributor which will distribute it as directed by the U.S. government’s allocation program. The U.S. government has purchased 300,000 doses of bamlanivimab and committed that Americans will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product’s administration.
The FDA EUA is not full approval. Lilly is required to continue testing and keeping records and have an independent third party review the records of use. Lilly is required to report any adverse affects to the FDA.
Photo courtesy Eli Lilly & Co.
