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FDA grants Emergency Use Authorization to Eli Lilly’s antibody drug to treat COVID-19

Published on 10/11/20 at 12:05pm

The FDA has granted Emergency Use Authorization (EUA) to Eli Lilly’s antibody drug bamlanivimab for the treatment of COVID-19 patients who are not hospitalised but are at risk of serious illness because of their age or underlying health conditions. 

The drug is a monoclonal antibody which is a laboratory-made protein that mimics the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab specifically is directed against the spike protein of COVID-19 and is designed to block the virus’ attachment and entry into human cells. 

The approval means that the drug will be available to anyone over the age of 65 who was recently diagnosed with mild to moderate coronavirus symptoms, or for patients over 12 who have underlying health conditions that put them at risk of serious illness. The drug was not authorised for hospitalised patients, nor for those who required oxygen therapy due to COVID-19, as it could worsen clinical outcomes for such patients. 

The FDA granted EUA based on its analysis of a Phase 2 randomised, double-blind, placebo-controlled clinical trial in 465 non-hospitalised adults with mild to moderate symptoms. Most patients, including those receiving placebo, cleared the virus by day 11. In terms of hospitalisations, emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients. 

Patrizia Cavazzoni, Acting Director of the FDA’s Center for Drug Evaluation and Research, commented on the decision: “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. We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”

The US Government has purchased 300,000 doses of the treatment and has said that Americans will not pay out of pocket costs if they need it. 

Conor Kavanagh

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