The neutralizing antibody is authorized for use in adult and pediatric COVID-19 patients over 12 who’ve tested positive and are at risk for a severe infection or hospitalization.
The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to drugmaker Eli Lilly and Company for the investigational antibody bamlanivimab to treat mild to moderate COVID-19.
According to a news release from the company, the single intravenous infusion of the drug should be administered as soon as possible after an adult or pediatric patient older than 12 tests positive for the COVID-19 coronavirus and within 10 days of symptom onset, if the patient is at-risk of progressing to severe COVID-19 and could be hospitalized.
"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," David A. Ricks, chairman and CEO of Lilly, says in the release. "The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most."
A separate release from the FDA says that the EUA does not authorize the drug’s use in patients who are already hospitalized with COVID-19 or require oxygen therapy due to the disease and if it is administered to these patients it could be associated with worse clinical outcomes.
“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “Through our Coronavirus Treatment Acceleration Program, the FDA continues to work around the clock and use every tool at our disposal toward these efforts.”
According to the company, the U.S. government will allocate 300,000 doses of the antibody to high-risk patients, at no out-of-pocket cost to patients.