FDA Rescinds EUA for Eli Lilly’s Monoclonal COVID-19 Antibody
The agency determined that the known benefits of the COVID-19 antibody alone no longer outweigh the known and potential risks for its authorized use.
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By - FDA recently revoked the emergency use authorization that allowed for Eli Lilly & Company’s monoclonal COVID-19 antibody, bamlanivimab, to be used for coronavirus treatment in adults and pediatric patients.
The agency determined that the known benefits of bamlanivimab alone no longer outweigh the known and potential risks for its authorized use.
The decision was based on FDA’s ongoing analysis of emerging scientific data, including the sustained increase of SARS-CoV-2 viral variants that are resistant to the drug.
Specifically, as of mid-March 2021, nearly 20 percent of viruses sequenced in the US were reported as variants expected to be resistant to bamlanivimab alone. This number increased by about 5 percent from mid-January 2021.
Resistance increases the risk for treatment failure. Therefore, FDA stated that the criteria for an authorization are no longer met.
“While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the announcement.
“We urge the American public to seek out these therapies when needed while we continue to use the best data available to provide patients with safe and effective treatments during this pandemic,” Cavazzoni continued.
In mid-November, FDA issued an emergency use authorization for bamlanivimab alone.
The authorization allowed healthcare providers to administer a single-dose of the drug in infected patients 12 years of age or older as long as they weighed 88 pounds.
The authorization also stated that the treatment can be administered to patients who are at risk for severe COVID-19 or hospitalization, including patients 65 years of age or older with underlying medical conditions.
At the time, FDA based its authorization on data from the Phase 2 BLAZE-1 trial that evaluated 465 non-hospitalized COVID-19 patients.
The trial found that bamlanivimab reduced viral load and rates of symptoms in hospitalizations. Specifically, the drug reduced COVID-related hospitalizations or emergency room visits in patients within 28 days after treatment compared to placebo.
Although FDA is now revoking the authorization for bamlanivimab, the agency stressed that alternative antibody therapies remain available under emergency use authorization.
The currently available drugs include REGEN-COV, as well as bamlanivimab and etesevimab administered together. The drugs are authorized for the same uses as the previous authorization for bamlanivimab alone had.
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, including 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.
But just last week, Eli Lilly and Company requested that FDA revoke the emergency use authorization for bamlanivimab.
The decision was based on the availability of bamlanivimab and etesevimab together, as well as the evolving variant COVID-19 landscape in the US. Notably, the company’s request was not due to any new safety concerns.
The request is Eli Lilly and Company’s 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 have access to the combination treatment.
In the recent announcement, FDA stated that it has a responsibility to regularly review the appropriateness of an authorization and will continue to review emerging information associated with the emergency uses for the authorized products.
