FDA Authorizes Emergency Use for Monoclonal Antibody Drug Amid $720 Million Deal

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

The Food and Drug Administration (FDA) on Friday announced it handed down an emergency use authorization for Eli Lilly and Company’s bebtelovimab, a monoclonal antibody treatment for COVID-19.

The drug is intended for the treatment of mild to moderate COVID-19, the illness caused by the CCP (Chinese Communist Party) virus in patients aged 12 and older who tested positive for COVID-19 and are “at high risk for progression to severe” disease, including hospitalization or death.

It also applies to individuals for which “alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate,” according to an FDA news release.

“Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19,” said the federal drug regulator. “Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.”

The agency and Eli Lilly said that bebtelovimab works by binding with the CCP virus spike protein that causes COVID-19 and is similar to other monoclonal antibodies that have been approved by the FDA and other drug regulators.

Meanwhile, the drug also appears to work against the Omicron subvariant BA.2, which some researchers have said is more contagious than the initial strain, according to the agency.

COVID-19-related hospitalizations and deaths through day 29 for those who received bebtelovimab alone or with other monoclonal antibodies were lower than the placebo rate in previous trials of the drug, the FDA and Eli Lilly said.

“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” said Patrizia Cavazzoni, M.D, director of the FDA’s Center for Drug Evaluation and Research, in the release. “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.”

Eli Lilly, in a statement released on Feb. 10, announced that it came to an agreement with the federal government to supply 600,000 doses of the drug for $720 million.

“The supply agreement calls for the delivery of up to 600,000 doses no later than March 31, 2022 with an option of 500,000 additional doses no later than July 31, 2022,” according to the company.

The FDA said that potential side effects include itching, rash, nausea, vomiting, and infusion-related reactions.