- The FDA’s authorization expands the drug’s use to fight Covid-19 to people under the age of 12
- The therapy, Bamlanivimab plus Etesevimab, was previously authorized for children aged 12 years and older and weighed at least 88 pounds.
- Bamlanivimab/Etesevimab is a combination of two monoclonal antibodies, Bamlanivimab and Etesevimab, administered together via intravenous infusion as a treatment for COVID-19.
The U.S. Food and Drug Administration on Friday authorized the use of Eli Lilly’s (LLY.N) COVID-19 dual-antibody therapy in treating mild to moderate symptoms in all children, including newborns, who are at risk of severe illness.
The therapy, Bamlanivimab plus Etesevimab, was previously authorized for children aged 12 years and older and weighed at least 88 pounds.
“Children under one year of age, who are exposed to the virus that causes COVID-19, may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
The FDA authorization also allows the administration of the therapy as a preventive measure in children who are exposed to the virus.
Bamlanivimab Plus Etesevimab
Bamlanivimab/Etesevimab is a combination of two monoclonal antibodies, Bamlanivimab and Etesevimab, administered together via intravenous infusion as a treatment for COVID-19. Both types of antibody target the surface spike protein of SARS‑CoV‑2.
Bamlanivimab and Etesevimab, administered together, are authorized in the United States for the treatment of mild-to-moderate COVID-19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. They are also authorized, when administered together, for use after exposure to the SARS-CoV-2 virus for post-exposure prophylaxis (prevention) for COVID-19 and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus.
Etesevimab is a monoclonal antibody against the surface spike protein of SARS‑CoV‑2.
Eli Lilly licensed Etesevimab from Junshi Biosciences
Bamlanivimab is an IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS‑CoV‑2. The aim is to block viral attachment and entry into human cells, thus neutralizing the virus, and help preventing and treating COVID-19.
About Eli Lily
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War.
Lilly’s notable achievements include being the first company to mass-produce the polio vaccine developed by Jonas Salk, and insulin. It was one of the first pharmaceutical companies to produce human insulin using recombinant DNA including Humulin (insulin medication), Humalog (Insulin Lispro), and the first approved biosimilar insulin product in the US, Basaglar (Insulin Glargine).
Lilly is currently the largest manufacturer of psychiatric medications and produces Prozac (fluoxetine), Dolophine (methadone), Cymbalta (duloxetine), and Zyprexa (olanzapine).
The company is ranked 123rd on the 2019 Fortune 500. It is ranked 221st on the Forbes Global 2000 list of the largest public companies in the world and 252nd on the Forbes list of America’s Best Employers.
Eli Lilly is a full member of the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations (EFPIA).