FDA Grants Emergency Use Authorization for New Antibody Drug

The emergency use authorization for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients at least 12 years of age who are at high risk for severe disease. Eli Lilly and Co. produces the treatment. On Thursday, Lilly announced that the United States would purchase 600,000 doses of the drug in a $720 million deal.

The emergency use authorization comes as good news for people at high risk for severe COVID. The mutations of Omicron had rendered ineffective some of the previously available monoclonal antibody treatments, leaving doctors with fewer treatment options.

"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 in a statement. "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 works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients, the FDA said.

The agency based its decision on a series of clinical trials involving more than 700 COVID patients. The rates of hospitalization and death seen in those who received bebtelovimab alone or with other monoclonal antibodies were generally lower than those of a group that received a placebo, the FDA said.

"Lilly has worked hard to fight this pandemic. Early in 2021, prior to the identification of the Omicron variant, Lilly scientists were already working to develop bebtelovimab as a broadly neutralizing antibody that could be used to fight a highly mutated variant, should one emerge," Dr. Daniel Skovronsky, Lilly's chief scientific and medical officer and president of Lilly Research Laboratories, said in a company statement.

"With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic," Skovronsky said.

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