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FDA issues emergency use authorization for Eli Lilly's COVID-19 antibody combo

FDA issues emergency use authorization for Eli Lilly's COVID-19 antibody combo
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The Food and Drug Administration (FDA) on Tuesday gave emergency use authorization for a new combination antibody drug from Eli Lilly that the company says can treat mild and moderate cases of the coronavirus.

The authorization from the FDA is for a treatment that uses both bamlanivimab and etesevimab. It can be used to treat mild or moderate COVID-19 cases in adults and pediatric patients who test positive for the virus and who are at high risk for progressing to severe illnesses. The treatment cannot be used for patients who are hospitalized or require oxygen therapy from the coronavirus.

The FDA had previously authorized a treatment from Eli Lilly that just used bamlanivimab. 

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The new authorization permits the federal government to distribute the treatment to state and territorial health departments to give to certain facilities.

“Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic,” said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research.

The emergency use authorization follows data showing that bamlanivimab and etesevimab administered together reduced the risk of COVID-19 hospitalizations and death by 70 percent.

Eli Lilly touted the authorization, noting that it will add to the bamlanivimab that is already in circulation and it says has helped reduce hospitalizations.

“Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat COVID-19,” said Daniel Skovronsky, Eli Lilly’s chief scientific officer. “Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.”

Eli Lilly has manufactured 250,000 doses of the treatment during the first quarter of 2021 and plans to have made as many as a million doses by the middle of the year. 

The news comes as cases decrease across the country but remain at alarmingly high levels. There are still over 27 million cases, and over 468,000 people in the country have died from the virus. Concerns over the virus have only risen as a number of variants — which appear more infectious than the original strain — spread across the globe.

“With the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world,” said Skovronsky.