- Eli Lilly is awarded Emergency Use Authorization (EUA) by the FDA for its monoclonal antibody for the treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients.
- U.S. government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication.
The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. As part of the EUA, 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.
Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, 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 authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.
Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government’s allocation program. For the most up-to-date information regarding access to bamlanivimab, patients should speak with their healthcare providers, and health care providers should contact their state health department directly.
Bamlanivimab is authorized for use under an EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
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Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Source: Hit Consultant