FDA authorizes Eli Lilly’s new monoclonal antibody drug for COVID-19

key takeaways

  • Lilly’s monoclonal antibody therapy bebtelovimab has been granted emergency use authorization by the FDA for mild to moderate COVID.
  • The drug appears to be effective against Omicron and other variants of interest.
  • The FDA said the drug should only be used when other treatment options are unavailable or clinically inappropriate.

Federal regulators approved a new monoclonal antibody to treat mild to moderate COVID-19 on February 11.

The drug, bebtelovimab, is approved for people 12 and older who have tested positive for COVID-19 and are at higher risk for hospitalization or death. The U.S. Food and Drug Administration (FDA) says it should only be used if there are no other treatment options.

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

What is a subvariant?What you should know about Omicron BA.2

“With variants such as Omicron, treatment options remain limited,” said Daniel Skovronsky, MD, Lilly’s chief scientific and medical officer and president of Lilly Research Laboratories, in a statement.

Omicron now accounts for an estimated 96% of COVID-19 cases in the United States, while the Omicron sub-variant BA.2 may account for another 4%.

The U.S. government agreed to buy as many as 600,000 doses of bebtelovimab for at least $720 million.

what does this mean to you

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

Filling the gap in COVID-19 treatment

In January, the federal government stopped sending some of Regeneron and Eli Lilly’s monoclonal antibody courses to certain parts of the United States after the drugs were found to be ineffective against Omicron.

Lilly’s previous preparations of monoclonal antibodies were a mixture of two drugs called bamlanivimab and etesevimab. Bebtelovimab is a new monoclonal antibody created with viral variants such as Omicron in mind.

Lilly submitted data to the FDA from a Phase 2 clinical trial of about 700 people, some at low risk and others at high risk for severe COVID. In each group, some participants who received bebtelovimab recovered faster and saw a reduction in their viral load after five days, compared with those who received a placebo.

The authorized dose is 175 mg administered intravenously for at least 30 seconds. Like other monoclonal antibodies, bebtelovimab should not be used in patients who are already hospitalized.

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

GlaxoSmithKline’s monoclonal antibody, called sotrovimab, was 85 percent effective in preventing hospitalizations in clinical studies and appears to be effective against Omicron, according to the preprint report. The drug received emergency use authorization in December 2021, and the government increased its purchases of the drug last month.

In addition to monoclonal antibody therapy, oral antiviral drugs offer a complementary option for patients with mild disease who wish to reduce the risk of hospitalization. Pfizer and Merck’s antiviral pills have been touted as having the potential to reduce the severe consequences of COVID-19 without requiring patients to be treated in the hospital.

How do Merck and Pfizer’s COVID Pills compare?

While Pfizer’s drug Paxlovid is highly effective against variants that include Omicron, Merck’s molnupiravir carries a similar qualifier to bebtelovimab: it’s only for those “can’t get FDA-authorized alternatives to COVID-19″ 19 for whom a treatment regimen or clinically unavailable person” is appropriate. ”

Veklury (remdesivir) also appears to neutralize Omicron and maintain its FDA authorization nationwide. Antiviral intravenous fluids can be used to reduce the risk of hospitalization in many patients with mild to moderate COVID-19.

COVID-19 antiviral drugs in short supply

Hospitals continue to see large numbers of patients infected with Omicron, while supplies of antiviral drugs and monoclonal antibodies that remain effective against this variant remain low. Health officials hope Lilly’s new drug will help ease the pressure on the supply of COVID treatments.

“As new variants of the virus continue to emerge, this authorization is an important step in addressing the need for more tools to treat patients,” 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 that you may have updated information as you read this article. For the latest updates on COVID-19, visit our Coronavirus news page.