Drug regulators in the US have given emergency use approval for Eli Lilly and Co's investigational monoclonal antibody therapy for the treatment of mild-to-moderate Covid-19 in adult and pediatric patients.
The treatment called, bamlanivimab, is authorised for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40kg, and who are at high risk for progressing to severe Covid-19 and/or hospitalisation, the US Food and Drug Administration (FDA) said on Monday.
In clinical trials, the treatment was shown in to reduce Covid-19-related hospitalisation or emergency room visits.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses.
Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus' attachment and entry into human cells.
"The FDA's emergency authorisation of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating Covid-19 patients," said Patrizia Cavazzoni, Acting Director of the FDA's Center for Drug Evaluation and Research.
"We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available."
However, the US FDA noted that bamlanivimab is not authorised for patients who are hospitalised due to Covid-19 or require oxygen therapy due to Covid-19.
A benefit of bamlanivimab treatment has not been shown in patients hospitalised due to Covid-19.
Also Read: AstraZeneca COVID-19 Vaccine Data expected by the end of this year
As many as one million doses of the single-antibody therapy are expected to be supplied by Lilly in the fourth quarter, with 100,000 doses available in October. The firm has signed a deal of $1,250 per dose with the US government and along with selling the drug to other countries.
Several other drugmakers, including Regeneron Pharmaceuticals Inc, are testing antibody treatments for Covid-19.
With agency inputs