The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Eli Lilly and Company’s monoclonal antibody, bamlanivimab (LY-CoV555) 700mg, to treat patients recently diagnosed with Covid-19.

Bamlanivimab is an investigational neutralising antibody that targets the spike protein of SARS-CoV-2 and designed to inhibit the virus’ attachment and entry into human cells.

The monoclonal antibody therapy is authorised for patients aged 12 years or above with mild to moderate Covid-19, who are at high risk for progressing to severe disease and/or hospitalisation.

A single intravenous infusion of bamlanivimab should be administered as soon as possible after a positive Covid-19 test and within ten days of onset symptoms.

The EUA granted by FDA aids in distribution and emergency use of the monotherapy.

Eli Lilly chairman and CEO David Ricks said: “This emergency authorisation 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.”

The EUA is supported by results from a Phase II BLAZE-1 trial in patients with recently diagnosed mild to moderate Covid-19 in the outpatient setting.

Data from the randomised, double-blind, placebo-controlled trial showed patients who received bamlanivimab had reduced viral load and rates of symptoms and hospitalisation.

The EUA helps in making a treatment or medicine available to aid in diagnosis, treatment or prevention of life-threatening diseases when no adequate and approved options are available.

With the latest development, Lilly will initiate shipping bamlanivimab to national distributor AmerisourceBergen , which will distribute it as directed by the US government’s allocation programme.

Last month, Lilly submitted an application to the FDA seeking EUA for LY-CoV555 monotherapy for treating higher-risk patients with mild-to-moderate Covid-19.