The COVID-19 monoclonal antibody treatment known as bebtelovimab was granted emergency use authorization (EUA) last week by the U.S. Food and Drug Administration (FDA), thanks to its displayed capabilities against the dominant Omicron variant.
Omicron has changed the field of the ongoing pandemic, forcing the FDA to remove authorization from two other, now ineffective antibody treatments even as the agency authorized this new production from Eli Lilly and Co. When used to treat COVID-19 cases, bebtelovimab has been shown in clinical and nonclinical data – including a Phase 2, randomized, single-dose efficacy trial – to likely be successful against the variant even as it tanked other treatments’ efficacy.
As a result, the FDA cautioned there are also no other adequate, approved, or available alternative treatments to bebtelovimab for use against COVID-19. It is meant for patients with mild or moderate cases.
“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said. “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.”
The new treatment is authorized for use both on adult and pediatric patients at least 12 years old and weighing at least 88 pounds. They must have tested positive for COVID-19 and represent a high risk for progression to the disease’s more serious effects, including hospitalization or death.
If a patient has progressed to hospitalization or the need for oxygen therapy, it is too late to use bebtelovimab. The treatment has not been tested under such conditions, and the FDA warned it might worsen clinical outcomes for hospitalized COVID-19 patients.