The new treatment, a monoclonal antibody therapy, aims to treat ‘mild to moderate’ COVID-19 cases, according to the US Food and Drug Administration. The treatment, called bamlanivimab, has been developed by Eli Lilly and Co. It was approved for use by the FDA yesterday, though its safety and effectiveness remain under investigation.
It works by using artificial proteins manufactured in a lab which target the spike protein of the COVID-19 virus.
The FDA said the proteins are “designed to block the virus’ attachment and entry into human cells.”
Dr Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, added: “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.”
There are some limitations in place regarding who may receive the treatment.
For example, the drug cannot be used on patients who are hospitalised with the virus or who require oxygen therapy.
The FDA said: “A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19.
“Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
“This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”
The Emergency Use Authorisation is not the same as a standard FDA drug approval.
Under an EUA, the FDA allows the use of a medical product to treat patients even though it has not been officially approved.
The FDA may only do so in the case of an emergency to treat serious illnesses when there are no alternative treatments available.
The federal authority has issued EUAs before, notably during the outbreak of the H1N1 virus in 2009.
In that year and in 2010, a total of 22 products received EUAs in order to assist the US’ response, according to a National Academies report.
These included diagnostic tests as well as antiviral medications and protective kit.