The U.S. Food and Drug Administration (FDA) announced Monday it issued an emergency use authorization (EUA) for Eli Lilly’s antibody therapy to treat mild to moderate coronavirus infections.
Bamlanivimab, the single antibody treatment has to be administered in a hospital or health care setting, per CNN. The monoclonal therapy is the first of its kind to be given the go-ahead from the FDA to treat the coronavirus.
“Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” according to a statement from the FDA.
Monoclonal antibodies are proteins made in a lab that mimic the immune system’s ability to fight off viruses. (RELATED: Pfizer Tries To Distance Itself From Trump Admin’s Operation Warp Speed As Vaccine Sees Success In 1st Analysis)
“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in the FDA release. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
The treatment can only be given to those who are older than 12 years, weigh more than 88 pounds and are at high risk for getting a severe case of the coronavirus, per the FDA. Patients who are hospitalized due to COVID-19 or are on oxygen cannot receive the therapy.
Bamlanivimab should be used as soon as possible after a patient tests positive for the coronavirus and within 10 days of developing symptoms, according to The New York Times (NYT).
Breaking News: The F.D.A. gave emergency approval to an experimental antibody treatment for Covid-19 made by Eli Lilly that was given to Chris Christie, the former New Jersey governor. It’s similar to one President Trump received.https://t.co/qGDGSoRey0
— The New York Times (@nytimes) November 10, 2020
Eli Lilly reportedly struck a $375 million deal in October with the government to provide its antibody treatment once the FDA approved the treatment. Eli Lilly will provide 300,000 doses over the next two months and nearly 650,000 doses next year, per the NYT.
The news comes just after Pfizer announced their coronavirus vaccine is over 90% effective and White House Coronavirus Task Force member Dr. Anthony Fauci said the vaccine could be distributed by the end of the year.