Lilly gets FDA EUA for bebtelovimab in mild-to-moderate Covid-19
Eli Lilly and Company (Lilly) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for bebtelovimab for the treatment of mild-to-moderate Covid-19.
According to Lilly, bebtelovimab is a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2, which has also shown capability to neutralize against the Omicron variant.
Under the FDA EUA, bebtelovimab can be used in mild-to-moderate Covid-19 in adults as well as pediatric patients, 12 years of age and over, and weighing at least 40kg.
The drug can be used in patients, who are at highly prone to advance to severe Covid-19, which is hospitalization or death. The EUA also allows bebtelovimab to be used in patients for whom other FDA approved or authorized treatment options for Covid-19 are not accessible or appropriate clinically.
Lilly gets FDA EUA for bebtelovimab in mild-to-moderate Covid-19. Photo courtesy of Momoneymoproblemz/Wikipedia.org.
Lilly said that bebtelovimab’s authorized dose is 175mg in the form of an intravenous injection, which has to be given for at least 30 seconds.
Daniel Skovronsky — Lilly chief scientific and medical officer and president of Lilly Research Laboratories said: “As a global pharmaceutical company, 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.
“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.”
The FDA EUA for bebtelovimab is mainly backed by the findings of the phase 2 BLAZE-4 clinical trial. The mid-stage clinical trial evaluated treatment of non-hospitalized patients with mild-to-moderate Covid-19 with 175mg bebtelovimab alone or in combination with 700mg bamlanivimab and 1,400 mg of etesevimab.