Bamlanivimab – Lilly’s COVID Neutralizing Antibodies got Emergency Authorization

In a major breakthrough in the fight against COVID-19, the U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for bamlanivimab, a monoclonal antibody therapy developed by Eli Lilly and Company. Bamlanivimab is designed to block the virus’s attachment and entry into human cells, thereby neutralizing the virus and potentially preventing and treating COVID-19.

Bamlanivimab is the first monoclonal antibody to receive an EUA for COVID-19. It is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

The EUA is based on data from the BLAZE-1 clinical trial, which showed that bamlanivimab reduced viral load, symptoms, and hospitalization rates in patients with mild to moderate COVID-19. The safety and effectiveness of bamlanivimab for the treatment of COVID-19 continue to be evaluated in ongoing clinical trials.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. The benefit of bamlanivimab has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Eli Lilly and Company is working with the U.S. government to distribute bamlanivimab to hospitals and healthcare facilities across the country. The U.S. government has committed to provide 300,000 doses of bamlanivimab through the end of 2020, with an option to purchase up to 650,000 additional doses through June 30, 2021.

Bamlanivimab is a promising tool in the arsenal against COVID-19. It has the potential to reduce the severity of the disease, prevent hospitalizations, and save lives. However, it is not a substitute for prevention measures such as wearing a mask, social distancing, and washing hands. Together, we can overcome this pandemic and protect our health and well-being.