Key TakeawaysLilly’s monoclonal antibody treatment, called bebtelovimab, received FDA emergency use authorization for mild-to-moderate COVID.The drug appears to be effective against Omicron and other variants of concern.The FDA said the drug should be administered only when other treatment options aren’t accessible or clinically appropriate.

Key Takeaways

Lilly’s monoclonal antibody treatment, called bebtelovimab, received FDA emergency use authorization for mild-to-moderate COVID.The drug appears to be effective against Omicron and other variants of concern.The FDA said the drug should be administered only when other treatment options aren’t accessible or clinically appropriate.

Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19.

The drug, bebtelovimab, is authorized for people 12 years and older who test positive for COVID-19 and are at high risk of hospitalization or death. The Food and Drug Administration (FDA) said it’s to be administered only when other treatment options aren’t available.

What’s a Subvariant? What You Should Know About Omicron BA.2

“With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and healthcare providers who continue to battle this pandemic,”Daniel Skovronsky, MD, PhD, Lilly’s chief scientific and medical officer and president of Lilly Research Laboratories, said in astatement.

Omicron now accounts for an estimated 96% of the COVID-19 cases in the United States, while the Omicron subvariant BA.2 likely makes up the other 4%.

The U.S. government agreed to purchase up to 600,000 doses of bebtelovimab for at least $720 million.

What This Means For YouMonoclonal antibodies, including bebtelovimab, can minimize illness in people infected with COVID-19. But they are not a substitute for vaccination against COVID-19. Being vaccinated is still the best way to protect yourself and others.

What This Means For You

Monoclonal antibodies, including bebtelovimab, can minimize illness in people infected with COVID-19. But they are not a substitute for vaccination against COVID-19. Being vaccinated is still the best way to protect yourself and others.

Filling a Void in COVID-19 Treatments

Lilly’s prior monoclonal antibody formulation was a mixture of two drugs called bamlanivimab and etesevimab. Bebtelovimab, the new monoclonal antibody, was created with viral variants like Omicron in mind.

Lilly presented data to the FDA from aphase 2 clinical trialof about 700 people, some of whom were low risk and others who were at high risk of severe COVID. In each group, some participants who received bebtelovimab recovered faster and saw a reduced viral load after five days, compared to those who had the placebo.

The authorized dose is 175 mg given intravenously over at least 30 seconds. Like other monoclonal antibodies, bebtelovimab shouldn’t be used for patients who are already hospitalized.

Possible side effects of the drug include itching, rash, infusion-related reactions, nausea, and vomiting.

GlaxoSmithKline’s monoclonal antibody, called sotrovimab, is 85% effective at preventing hospitalizations in clinical studies and appears effective against Omicron, according to pre-print reports.The drug received emergency use authorization in December 2021 and the government increased its purchase of the drug last month.

How Do Merck and Pfizer’s COVID Pills Compare?

Veklury (remdesivir), too, appears to neutralize Omicron andmaintains its FDA authorizationnationwide. The antiviral IV infusion can be used to reduce the risk of hospitalization in many individuals with mild-to-moderate COVID-19.

COVID-19 Antivirals Are in High Demand and Short Supply

Hospitals are continuing to see high volumes of patients infected with Omicron while the supply of the antivirals and monoclonal antibodies that retain efficacy against the variant remain low. Health officials are hoping that Lilly’s new drug will help ease the strain on COVID treatment supply.

“This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge," Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.

3 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Centers for Disease Control and Prevention.COVID data tracker: variant proportions.Cathcart AL, Havenar-Daughton C, Lempp FA, et al.The dual function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate potent in vitro and in vivo activity against SARS-CoV-2.bioRxiv. Preprint posted online December 15, 2021. doi:10.1101/2021.03.09.434607Department of Health and Human Services.Biden administration secures 10 million courses of Pfizer’s COVID-19 oral antiviral medicine as additional tool to reduce hospitalizations and save lives.

3 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Centers for Disease Control and Prevention.COVID data tracker: variant proportions.Cathcart AL, Havenar-Daughton C, Lempp FA, et al.The dual function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate potent in vitro and in vivo activity against SARS-CoV-2.bioRxiv. Preprint posted online December 15, 2021. doi:10.1101/2021.03.09.434607Department of Health and Human Services.Biden administration secures 10 million courses of Pfizer’s COVID-19 oral antiviral medicine as additional tool to reduce hospitalizations and save lives.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Centers for Disease Control and Prevention.COVID data tracker: variant proportions.Cathcart AL, Havenar-Daughton C, Lempp FA, et al.The dual function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate potent in vitro and in vivo activity against SARS-CoV-2.bioRxiv. Preprint posted online December 15, 2021. doi:10.1101/2021.03.09.434607Department of Health and Human Services.Biden administration secures 10 million courses of Pfizer’s COVID-19 oral antiviral medicine as additional tool to reduce hospitalizations and save lives.

Centers for Disease Control and Prevention.COVID data tracker: variant proportions.

Cathcart AL, Havenar-Daughton C, Lempp FA, et al.The dual function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate potent in vitro and in vivo activity against SARS-CoV-2.bioRxiv. Preprint posted online December 15, 2021. doi:10.1101/2021.03.09.434607

Department of Health and Human Services.Biden administration secures 10 million courses of Pfizer’s COVID-19 oral antiviral medicine as additional tool to reduce hospitalizations and save lives.

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