Eli Lilly Asks FDA to Revoke the EUA for COVID-19 Antibody Drug

Eli Lilly and Company recently requested that FDA revoke the emergency use authorization for its COVID-19 antibody treatment.

The FDA’s authorization has allowed providers to use 700 milligrams of bamlanivimab to treat COVID-19 patients.

The company based its decision on the availability of bamlanivimab and etesevimab together, as well as the evolving variant COVID-19 landscape in the US. The request is not due to any new safety concerns. 

"Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19," Daniel Skovronsky, MD, PhD, chief scientific officer and president of Eli Lilly and Company, said in the announcement.

"With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Skovronsky continued. 

Eli Lilly and Company’s request is the final step in its transition to only supply bamlanivimab and etesevimab for administration together in the US for COVID-19. All sites in the US now have access to the combination treatment. 

In mid-February, FDA issued an emergency use authorization to the combination of bamlanivimab and etesevimab for infected adult and pediatric patients. 

Together, the antibodies neutralize more of the emerging COVID-19 variants in the US than bamlanivimab alone. 

This includes the B.1.427/B.1.429 California strain that currently accounts for over 50 percent of the virus in California and over 10 percent across various other states.

Although bamlanivimab alone should no longer be administered in the US, according to Eli Lilly, sites of care should not dispose of bamlanivimab supply. Rather, they should order etesevimab to pair with it, an Eli Lilly and Company spokesperson said.

EMA Begins Review of GSK-Vir COVID-19 Monoclonal Antibody 

GSK and Vir Biotechnology recently announced that the European Medicines Agency (EMA) has started a review of its COVID-19 monoclonal antibody, VIR-7831.

The antibody is intended for the treatment of adults and adolescents infected with coronavirus who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. 

The review, which is being carried out by the EMA’s Committee for Human Medicinal Products (CHMP) will be based on data from an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE trial.

In the trial, researchers found that VIR-7831 as a monotherapy elicited an 85 percent reduction in hospitalization or death compared to placebo. Due to the positive findings, GSK and Vir Biotechnology stopped the Phase 3 trial last week. 

CHMP will provide EU-wide recommendations for national authorities who can make evidence-based decisions on the early use of the antibody.  

Additionally, the Australian Therapeutic Goods Administration (TGA) granted VIR-7831 a provisional determination last week. The antibody is the first to have been granted this designation.

Merck Discontinues Development of its COVID-19 Treatment 

Merck recently announced the discontinuation of its COVID-19 treatment, MK-7110, for the treatment of hospitalized patients infected with the virus. 

At the end of February, the company received feedback from FDA that additional data would be needed to support potential emergency use authorization of MK-7110.

Due to the additional research that would be needed, including clinical trials and research related to manufacturing at scale, the treatment would not become available until 2022. 

Given the timeline, the company decided it was best to discontinue development and focus on producing Johnson & Johnson’s COVID-19 vaccine. The company also said technical, clinical, and regulatory uncertainties and its need to concentrate on accelerating development and manufacture of the most viable therapeutics and vaccines also contributed to the decision.
At the end of January, Merck discontinued development of its COVID-19 vaccine candidates, V590 and V591, after the candidates elicited lesser immune responses than those reported for other promising vaccines.