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The Food and Drug Administration (FDA) on Tuesday gave emergency use approval for a new combination of Eli Lilly antibodies that the company says can treat mild and moderate cases of coronavirus.
The FDA clearance is for treatment using both bamlanivimab and etesevimab. It can be used to treat mild or moderate cases of COVID-19 in adults and pediatric patients who test positive for the virus and who are at high risk of progressing to serious illnesses. The treatment cannot be used for patients hospitalized or requiring oxygen therapy of the coronavirus.
The FDA previously cleared a treatment for Eli Lilly that simply used bamlanivimab.
The new authorization allows the federal government to distribute the treatment to state and territorial health departments to be dispensed at certain facilities.
“Today’s action, which provides an alternate treatment for COVID-19, reflects the FDA’s strong commitment to work with sponsors to expand potential treatment options that healthcare 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 taken together reduced the risk of hospitalization and death from COVID-19 by 70%.
Eli Lilly touted the clearance, noting that it would add to bamlanivimab which is already in circulation and has helped reduce hospitalizations.
“Lilly has dedicated our time, resources and expertise to discovering and developing therapies to treat COVID-19,” said Daniel Skovronsky, Scientific Director of Eli Lilly. “Bamlanivimab alone with emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are delighted to now add an additional treatment option with similar demonstrated clinical benefit.
Eli Lilly manufactured 250,000 doses of the treatment in the first quarter of 2021 and plans to manufacture up to one million doses by mid-year.
The news comes as cases decline across the country, but remain at alarming levels. There are still more than 27 million cases and more than 468,000 people in the country have died from the virus. Concerns about the virus have only increased as a number of variants – which appear to be more infectious than the original strain – have spread across the world.
“With the risk of resistance emerging when various strains of the virus emerge, bamlanivimab and etesevimab together could potentially provide efficacy against a wider range of natural variants of SARS-CoV-2 as these new strains spread throughout the world. world, ”said Skovronsky.
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