The Food and Drug Administration (FDA) has granted a license for emergency use (EUA) to Eli Lilly & Co's bamlanivimab based on trial data showing that a one-time infusion of treatment reduced the need for hospitalization or emergency room visits in high-risk COVID situations. 19 patients.\
US regulators on Monday authorized the emergency use of the first experimental anti-COVID-19 antibody drug in patients who have not been hospitalized but are at risk of developing serious illness due to their age or other conditions.
The Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Eli Lilly & Co's bamlanivimab based on trial data showing that a one-time infusion of treatment reduced the need for hospitalization or emergency room visits in high-risk COVID situations - 19 patients .
The drug is a monoclonal antibody - a widely used class of biotech drugs that in this case is a manufactured version of the human body's antibody to fight infection.
A similar treatment developed by Regeneron Pharmaceuticals Inc was presented to US President Donald Trump after he contracted the Coronavirus in early October. The country's chief infectious disease expert, Dr. Anthony Fauci, said this likely contributed to Trump's recovery.
In an emailed statement, the White House hailed the FDA decision as a "milestone."
Regeneron is also seeking EUA for its dual antibody against COVID-19.
The FDA said the nocturnal antibody can be used by anyone over the age of 65 who has recently been diagnosed with mild to moderate COVID-19 and in patients 12 years of age or older who have an underlying health condition that puts them at risk of serious illness.
It has not been licensed for hospitalized patients nor for those requiring oxygen therapy due to COVID-19 as it may exacerbate clinical outcomes for such patients. A US government-sponsored study of pamlinivimab in hospitalized COVID-19 patients was recently abandoned because the treatment had not been shown to be helpful.
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