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.
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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
department directly.
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.
References
- 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.
This article originally appeared on MPR
