FDA Grants Eli Lilly Drug EUA for Treatment of COVID-19

FDA announced on Feb. 11, 2022, that it has granted an Emergency Use Authorization (EUA) to Eli Lilly and Company for bebtelovimab, a monoclonal antibody (mAb) designed for treatment of COVID-19. The EUA covers treatment of mild to moderate COVID-19 symptoms in adult and pediatric patients, with a positive COVID-19 test, who are at high risk for progression to severe COVID-19 and for whom alternative FDA approved/authorized COVID-19 treatment options are not accessible or clinically appropriate. According to FDA’s press release, laboratory testing showed that bebtelovimab retains activity against both the omicron variant and the BA.2 omicron subvariant.

The decision was based on a Phase II, randomized, single-dose clinical trial evaluating the efficacy of bebtelovimab alone and bebtelovimab combined with other mAbs in treating mild to moderate COVID-19. Rates of COVID-19 related hospitalization and death through Day 29 seen in those who received bebtelovimab alone or with other mAbs were generally lower than the placebo rate reported in prior trials of other mAbs in high-risk patients. However, FDA notes that conclusions are limited because this data compares different clinical trials done at different times, with different dominant variants.

“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, director of FDA’s Center for Drug Evaluation and Research, in the press 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.”