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FDA Authorizes a New COVID-19 Monoclonal Antibody Drug From Eli Lilly | by heidi

 



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.


Manufactured by Eli Lilly, bebtelovimab appears to be effective against Omicron and other variants including BA.2, according to the company.


 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 health care 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 a statement.


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%.1



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


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

In January, the federal government stopped sending courses of certain monoclonal antibodies by Regeneron and Eli Lilly to some regions of the U.S. after it became clear that those drugs weren’t effective against Omicron.



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 a phase 2 clinical trial of 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.2 The drug received emergency use authorization in December 2021 and the government increased its purchase of the drug last month.


In addition to monoclonal antibody treatments, oral antivirals offer a supplemental option for people with mild disease looking to reduce their risk of hospitalization. Antiviral pills by Pfizer and Merck have been touted for their potential to diminish severe outcomes from COVID-19 without requiring patients to receive treatment in a hospital setting.3


 How Do Merck and Pfizer’s COVID Pills Compare?

While Pfizer’s drug Paxlovid is highly effective against variants including Omicron, Merck’s molnupiravir carries a qualifier similar to the one for bebtelovimab: It is to be used only in those “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”


Veklury (remdesivir), too, appears to neutralize Omicron and maintains its FDA authorization nationwide. 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.

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