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FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.
Eli Lilly’s bamlanivimab, an investigational monoclonal antibody treatment for COVID-19, has received an emergency use authorization (EUA) from FDA for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients who are at high risk for severe COVID-19 or hospitalization.
In the Nov. 9, 2020 announcement, FDA authorized use of the drug for patients 12 years of age or older, weighing at least 88 pounds, with positive results from direct SARS-CoV-2 viral testing. The authorization includes patients who are 65 years of age or older, or who have certain chronic medical conditions.
The treatment 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, FDA reported.
The bamlanivimab monoclonal antibody is directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. The antibody, which was identified from a blood sample taken from a patient who recovered from COVID-19, was developed in less than three months after it was discovered by AbCellera and researchers at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center, Lilly reported.
The EUA decision was based on interim analysis from a Phase II clinical trial of 465 non-hospitalized patients who received doses of 700 mg, 2800 mg, or 7000 mg, or a placebo. Most patients, including those receiving placebo, cleared the virus by day 11. However, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared with 10% in placebo-treated patients. The effects on viral load and on reduction in hospitalizations and ER visits, and on safety, were similar in patients receiving any of the three bamlanivimab doses, FDA reported.
The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
Lilly reported in a Nov. 9. 2020 press statement that it will begin shipping bamlanivimab immediately to AmerisourceBergen, which will distribute it according to a federal government allocation program, proportionally based on confirmed COVID-19 cases over the previous seven days. Lilly noted that the government purchased 300,000 doses of bamlanivimab; US patients will have no out-of-pocket costs for the medicine, although a fee may be charged for the product's administration.
Lilly noted in the statement that it has invested in large-scale manufacturing of bamlanivimab at risk and anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020. The company expects its supply to “increase substantially” in the first quarter of 2021, as additional manufacturing resources come online.
In announcing the EUA, FDA determined that when used to treat COVID-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug. FDA specified several quality measures to manufacture the drug under the EUA.