FDA Gives Emergency OK for New Monoclonal Treatment to Fight Omicron



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The Food and Drug Administration (FDA) issued an emergency use authorization Friday for a new monoclonal antibody treatment for some cases of COVID-19. The treatment, called bebtelovimab, is specifically for anyone over 12 with a mild to moderate case who is at a higher risk of severe illness and does not have access to alternative treatments, the FDA said in a news release. Trials for bebtelovimab showed it to be mostly effective in treating people infected with the coronavirus who meet these conditions, giving health care professionals another tool to use when fighting the disease. The emergency authorization comes because of the demand for more COVID-19 treatments to deal with virus variants like the highly contagious Omicron strain, according to Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.”Today’s action makes available another monoclonal antibody that shows activity against Omicron, at a time when we are seeking to further increase supply,” Cavazzoni said Friday. “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.”Bebtelovimab is not for those with cases severe enough to require hospitalization or intubation because it has not been tested on patients with these kinds of cases. Also, other monoclonal antibody treatments have sometimes been shown to make COVID-19 worse in these instances. The FDA defines monoclonal antibodies as “laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses.” They are especially useful for those with weakened immune systems who may not have a strong immune response to a COVID-19 vaccine, according to Healthline. Monoclonal antibodies have been used against the Ebola virus and respiratory syncytial virus, as well as some chronic illnesses like rheumatoid arthritis, and are being developed to target cancer cells, according to Healthline. Bebtelovimab’s emergency authorization was supported by “clinical and nonclinical data” showing it worked on patients who fell within established parameters when used by itself and mixed with other monoclonal antibodies, the FDA’s release said.”When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks,” the release added. “There are no adequate, approved and available alternative treatments to bebtelovimab.”However, the FDA also stressed that bebtelovimab is not a replacement for COVID-19 vaccination and urged all those who can safely get a shot to do so. An emergency use authorization from the FDA is not the same as an approval. When determining whether to issue an emergency authorization, the agency “evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency,” the agency said.

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