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FDA Issues Emergency Approval to Eli Lilly’s Antibody Treatment

Eli Lilly's COVID-19 Antibody Vaccine

Key Takeaways

  • The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) of a coronavirus antibody treatment made by Eli Lilly. 
  • The antibody cocktail is called bamlanivimab and has been authorized for use in recently diagnosed, high-risk patients 12 years and older.
  • Eli Lilly said it plans to manufacture up to one million doses of bamlanivimab by the end of 2020.

The Food and Drug Administration (FDA) announced in a letter on Monday it would issue an emergency use authorization (EUA) of a COVID-19 neutralizing antibody treatment made by pharmaceutical company Eli Lilly. 

"This emergency authorization allows us to make a COVID-19 treatment available for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," Dave Ricks, Eli Lilly's chairman and CEO, said in a news release.

The possibility of viable treatment comes at a time when COVID-19 is infecting more than 140,000 people per day.

The treatment, called bamlanivimab (LY-CoV555), has been authorized for the treatment of mild to moderate COVID-19 in adults and children 12 years and older with a positive COVID-19 test, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, according to the company’s statement. The antibody cocktail should be administered as a single intravenous infusion within 10 days of developing COVID-19 symptoms.

“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” FDA Commissioner Stephen M. Hahn, MD, said in a November 9 news release. “Through our Coronavirus Treatment Acceleration Program, the FDA continues to work around the clock and use every tool at our disposal toward these efforts.”

Eli Lilly’s news was announced on the same day Pfizer said it had obtained positive early results from its Phase 3 vaccine trial. But Pfizer said in a statement that even with an approved EUA, it would not be able to deliver the bulk of its available doses until 2021.

Eli Lilly said it plans to manufacture up to one million doses of bamlanivimab by the end of 2020.

Patrizia Cavazzoni, MD

"The FDA’s emergency authorization of bamlanivimab provides healthcare professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients."

— Patrizia Cavazzoni, MD

What Is Bamlanivimab? 

The name might be hard to pronounce, but the purpose of these antibodies is simple: “[The] laboratory-made proteins mimic the immune system’s ability to fight off harmful antigens such as viruses,” the FDA said in its release about bamlanivimab.

Basically, bamlanivimab is an antibody cocktail that is aimed at COVID-19 proteins, which allows it to stop the virus from attaching and entering human cells. 

“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in the FDA’s release. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”

Both Lilly's Bamlanivimab and Regeneron's REGN-COV2, the antibody cocktail President Trump received when he was diagnosed with COVID-19, are still being reviewed. REGN-COV2, however, has not yet received EUA from the FDA.

What’s the Difference Between an EUA and Approval?

An EUA is not meant to be confused with FDA approval.  

“In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency,” the FDA said in its statement about bamlanivimab. “Based on the FDA’s review of the totality of the scientific evidence available, the agency determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate COVID-19."

In the case of an EUA, “the known and potential benefits outweigh the known and potential risks for the drug.”

What’s Next?

The U.S. government has purchased 300,000 doses of bamlanivimab that, according to Eli Lilly's news release, will come at no cost to Americans (with the exception of healthcare facilities that may charge for administering the drug).

 

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  1. Eli Lilly and Company. Lilly’s neutralizing antibody bamlanivimab (Ly-cov555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19. Updated November 9, 2020.

  2. Centers for Disease Control and Prevention. Covid-19 cases, deaths, and trends in the US. Updated November 11, 2020.

  3. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes monoclonal antibody for treatment of COVID-19. Updated November 9, 2020.

  4. Pfizer. Pfizer and Biontech announce vaccine candidate against Covid-19 achieved success in first interim analysis from phase 3 study. Updated November 9, 2020.