The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab, a potent neutralizing IgG1 monoclonal antibody directed against the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for the treatment of coronavirus disease 2019 (COVID-19).
Under the EUA, bamlanivimab is authorized for the 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 of age and older weighing at least 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The treatment should not be used in patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
The EUA was granted based on data from the ongoing randomized, double-blind, placebo-controlled phase 2 BLAZE-1 study, which evaluated bamlanivimab in 465 adults with mild to moderate COVID-19 symptoms in an outpatient setting. Patients were randomized to receive bamlanivimab 700mg (n=101), 2800mg (n=107), 7000mg (n=101), or placebo (n=156) as a single intravenous infusion. The prespecified primary end point was the change from baseline to day 11 in SARS-CoV-2 viral load; additional end points included the proportion of patients who experienced COVID-19 hospitalization, ER visit or death from baseline to day 29.
Interim analysis showed near complete viral clearance by day 11 in most patients, including those who received placebo. Pooled across all dose groups, 3% of patients treated with bamlanivimab had a COVID-19-related hospitalization or ER visit compared with 10% for placebo. As for safety, bamlanivimab was well tolerated with similar treatment emergent adverse events across all dose groups that were comparable to placebo. There were no drug-related serious adverse events reported.
Bamlanivimab is administered as a single intravenous infusion. As there is a potential for serious hypersensitivity reaction, including anaphylaxis, treatment should be administered in settings in which health care providers have immediate access to medications to treat severe infusion reaction. A fact sheet that details the criteria for patient selection as well as important safety information can be found here.
As for distribution, Lilly announced that shipments of bamlanivimab to AmeriSourceBergen, a national distributor, will begin immediately. In October, the Company announced an agreement with the US government to supply 300,000 vials of bamlanivimab 700mg; the federal government will be responsible for the allocation of the drug. Weekly allocations will be proportionally based on case counts in specific areas; AmeriSourceBergen will be provided with the list of sites that require a shipment of the treatment. To get up-to-date information on distribution, health care providers should contact their state health
Lilly expects to manufacture up to 1 million doses of bamlanivimab 700mg by the end of 2020 for global use, with a substantial increase in supply beginning in the first quarter of 2021.
- Coronavirus (COVID-19) update: FDA authorizes monoclonal antibody for treatment of COVID-19. [press release]. US Food and Drug Administration; November 9, 2020.
- Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency
use authorization for the treatment of recently diagnosed COVID-19. [press release]. Indianapolis, IN: Eli Lilly and Company; November 9, 2020.