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Eli Lilly wins FDA nod for COVID-19 antibody treatment

By Brian Buntz | November 10, 2020

The FDA issued an emergency use authorization (EUA) yesterday for the investigational monoclonal antibody therapy bamlanivimab (LY-CoV555) to treat COVID-19.

The drug from Eli Lilly (NYSE:LLY) is intended to reduce the risk of severe COVID-19 infections when administered within 10 days of developing symptoms.

The manufacturer indicates the drug for mild-to-moderate COVID-19 infections in adult and pediatric patients 12 years old or older weighing at least 88 pounds. People who are over 65 and obese could potentially benefit most from the drug, according to the FDA.

“[T]he 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,” said FDA Commissioner Dr. Stephen M. Hahn in a statement.

Preliminary trial data indicate that bamlanivimab reduces COVID-19-related hospitalization or emergency room visits in high-risk patients compared to a placebo, the agency noted. Bamlanivimab was designed to target the spike protein of the novel coronavirus, potentially blocking the virus’ entry into human cells.

Former New Jersey governor Chris Christie received the drug when he was infected with COVID-19, according to the New York Times.

HHS plans to allocate 300,000 doses of bamlanivimab immediately, according to an announcement from the health department. HHS and the Department of Defense had agreed to pay $375 million to buy 300,000 doses of the drug to add to a stockpile.

The FDA has not indicated the drug for hospitalized COVID-19 patients and suggested that monoclonal antibodies like bamlanivimab may worsen clinical outcomes for hospitalized patients requiring oxygen or mechanical ventilation.

Eli Lilly has also filed for an EUA to use Olumiant (baricitinib), a rheumatoid arthritis treatment, to hasten COVID-19 recovery time.


Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: coronavirus, covid-19, COVID-19 antibody treatment, Eli Lilly & Co., FDA, U.S. Department of Defense, U.S. Department of Health & Human Services
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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