The FDA issued an emergency use authorization (EUA) yesterday for the investigational monoclonal antibody therapy bamlanivimab (LY-CoV555) to treat COVID-19.
The drug from Eli Lilly (NYSE:LLY) is intended to reduce the risk of severe COVID-19 infections when administered within 10 days of developing symptoms.
The manufacturer indicates the drug for mild-to-moderate COVID-19 infections in adult and pediatric patients 12 years old or older weighing at least 88 pounds. People who are over 65 and obese could potentially benefit most from the drug, according to the FDA.
“[T]he 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,” said FDA Commissioner Dr. Stephen M. Hahn in a statement.
Preliminary trial data indicate that bamlanivimab reduces COVID-19-related hospitalization or emergency room visits in high-risk patients compared to a placebo, the agency noted. Bamlanivimab was designed to target the spike protein of the novel coronavirus, potentially blocking the virus’ entry into human cells.
Former New Jersey governor Chris Christie received the drug when he was infected with COVID-19, according to the New York Times.
HHS plans to allocate 300,000 doses of bamlanivimab immediately, according to an announcement from the health department. HHS and the Department of Defense had agreed to pay $375 million to buy 300,000 doses of the drug to add to a stockpile.
The FDA has not indicated the drug for hospitalized COVID-19 patients and suggested that monoclonal antibodies like bamlanivimab may worsen clinical outcomes for hospitalized patients requiring oxygen or mechanical ventilation.
Eli Lilly has also filed for an EUA to use Olumiant (baricitinib), a rheumatoid arthritis treatment, to hasten COVID-19 recovery time.
Filed Under: clinical trials, Drug Discovery, Infectious Disease