FDA authorizes emergency use of bebtelovimab for COVID-19
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The FDA authorized the emergency use of bebtelovimab, a monoclonal antibody that retains activity against the omicron variant, for the treatment of COVID-19, according to a press release.
“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” Patrizia Cavazzoni, M.D, director of the FDA’s Center for Drug Evaluation and Research, said 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.”
According to the release, the emergency use authorization (EUA) allows bebtelovimab to be used for cases of mild to moderate COVID-19 in adults and pediatric patients 12 years of age and older and weighing at least 40 kilograms, or about 88 pounds. The monoclonal antibody is not authorized for patients that are hospitalized or require oxygen support due to COVID-19.
Clinical and non-clinical data supports the EUA for bebtelovimab, according to the press release, with data from a phase 2, randomized, single-dose clinical trial evaluating bebtelovimab’s effectiveness against mild to moderate COVID-19 alone and combined with other monoclonal antibodies.
The EUA requires fact sheets to be made available to health care providers, patients and caregivers providing important information regarding bebtelovimab as a treatment for COVID-19, such as dosing instructions, drug interactions and potential side effects.
“Bebtelovimab is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended,” according to the press release. “The FDA has approved two vaccines and authorized others to prevent COVID-19 and the serious clinical outcomes associated with COVID-19, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster if eligible.”
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