The Food and Drug Administration has issued an Emergency Use Authorization for Eli Lilly & Co.’s COVID-19 antibody treatment drug bamlanivimab.
According to Indianopolis-based pharmaceutical company Eli Lilly, the EUA is based on positive results from Phase 2 trials when used on patients with recently diagnosed COVID. The drug uses laboratory-made antibodies, proteins the body usually creates to fight off infections, to handicap the spread of the virus in the body.
Data from the ongoing study, says Daniel Skovronsky, President of Lilly Research Laboratories, show the drug may help patients clear the virus and reduce hospitalizations. The drug is conditionally approved for use in mild to moderate COVID cases, but not for those who have been hospitalized or are receiving oxygen therapy.
“We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19,” said Skovronsky.
"This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients—adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," said David A. Ricks, CEO of Eli Lilly.
The U.S. has already purchased 300,000 doses of the treatment for $375 million and has promised that U.S. patients will not be charged for the medicine. The FDA grants emergency use authorizations to make promising drugs available to physicians for emergency cases before they receive full approval.
The drug is similar to the one produced by Regeneron Pharmaceuticals. Regeneron’s drug, which also uses antibodies to combat the virus, was administered to President Trump in October after the President was diagnosed with COVID.