Investigational COVID-19 antibody was authorized in a 700 mg dose for adults and pediatric patients 12 years and older and should be administered as soon as possible after diagnosis and within 10 days of symptom onset.
Bamlanivimab has received FDA Emergency Use Authorization (EUA) for the treatment of recently diagnosed, mild to moderate coronavirus disease 2019 (COVID-19) in high-risk patients. According to a press release, the US government will allocate 300,000 doses of the antibody drug to high-risk patients, with no out-of-pocket costs.
The antibody was approved in a 700 mg dose for adults and pediatric patients 12 years and older and should be administered as soon as possible after diagnosis and within 10 days of symptom onset, according to the press release. Bamlanivimab is administered via a single intravenous infusion.
“This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients—adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said Lilly Chairman and CEO David A. Ricks, in a press release.
EUAs are granted when the availability of a medication could help diagnose, treat, or prevent life-threatening disease when there are no adequate or approved alternatives available. Bamlanivimab remains an investigational drug, with ongoing safety and efficacy evaluations across a range of patient populations affected by COVID-19, according to the press release.
The BLAZE-1 trial showed that patients treated with bamlanivimab had a reduced viral load and rates of symptoms and hospitalization. Frequency and types of adverse events were similar between bamlanivimab and the placebo, with the majority of events being mild to moderate in severity. The EUA includes a warning for hypersensitivity, including anaphylaxis and infusion-related reactions.
“The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer, in a press release.
Lilly anticipates manufacturing up to 1 million doses by the end of 2020 and expects to increase that supply during the first quarter of 2021. In the United States, the federal government will make weekly allocation decisions based on confirmed COVID-19 cases in each state and territory over the previous week. State and territorial health departments will select sites of care, which will then confirm their need before receiving bamlanivimab distributed overnight.
Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19 [news release]. Eli Lilly; November 9, 2020. http://lilly.mediaroom.com/index.php?s=9042&item=138119. Accessed November 10, 2020.