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Eli Lilly asks FDA to revoke approval for use of antibody drug by itself

National Institutes of Health official Dr. Anthony Fauci (C) speaks about the coronavirus during a press briefing at the White House in Washington, D.C. Health and Human Services Secretary Alexander Azar (L) announced that the United States is declaring the virus a public health emergency and issued a federal quarantine order of 14 days for 195 Americans. Photo by Leigh Vogel/UPI | License Photo

April 16 (UPI) -- Drugmaker Eli Lilly said Friday it's asked federal regulators to revoke emergency use authorization for lone use of its COVID-19 antibody bamlanivimab, as it develops a combination therapy with the drug it says is more effective.

Eli Lilly made the request with the Food and Drug Administration due to coronavirus variants that may be resistant to bamlanivimab when it's used alone.

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The company said there are no safety issues with bamlanivimab, but when used with etesevimab it has shown to more effective.

"With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together," Eli Lilly Chief Scientific Officer Dr. Daniel Skovronsky said in a statement.

Lilly said more than 400,000 patients have been treated with bamlanivimab and that the drug has potentially prevented thousands of hospitalizations and deaths in the United States.

Bamlanivimab and etesevimab are being used in nearly two dozen countries, the company said.

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"Due to the rapidly evolving and geographically diverse nature of [COVID-19], continued scientific innovation remains critical to develop additional treatments," Eli Lilly added.

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