FDA Authorizes Eli Lilly Antibody Treatment That Fights Omicron

Topline

The Food and Drug Administration on Friday issued an emergency use authorization for a new monoclonal antibody treatment that drugmaker Eli Lilly says works against the coronavirus’ omicron variant, possibly putting a dent in months of intermittent supply shortages for effective Covid-19 treatments.

Eli Lilly and Company’s headquarters in Alcobendas, Madrid, Spain.

Cristina Arias/Cover/Getty Images

Key Facts

The FDA authorized the therapeutic—known as bebtelovimab—to treat mild to moderate Covid-19 in some people 12 years and older who are at high risk of severe symptoms and for whom alternative treatment options are not accessible or clinically appropriate.

On Thursday, Eli Lilly announced it had agreed to ship up to 600,000 doses of bebtelovimab to the U.S. government by March 31 for at least $720 million, with an option to deliver an additional 500,000 doses by July 31.

A clinical trial showed that bebtelovimab helped resolve some patients’ symptoms more quickly and reduce the level of virus in their bodies after five days, the FDA announced.

However, bebtelovimab’s ability to prevent severe Covid-19 symptoms has not yet been tested, the New York Times reported.

Key Background

Monoclonal antibody treatments help fight coronavirus infections by reinforcing the body’s natural immune response. Many of these treatments target the virus’s spike proteins, stopping the virus from reproducing. However, mutations to the omicron variant’s spike protein rendered several widely used monoclonal antibody treatments—including two earlier Eli Lilly treatments—ineffective. For several weeks, a drug by GlaxoSmithKline and Vir Biotechnology was the only available monoclonal antibody treatment that remained effective against the omicron variant, and in recent months some hospitals reported running low on monoclonal antibody supplies. Last month, the FDA rescinded its authorization of bamlanivimab and etesevimab, though many hospitals had already voluntarily stopped distributing it. However, company-sponsored lab tests showed Eli Lilly’s new drug still works against omicron, including the BA.2 omicron subvariant. The new drug and anti-Covid pills from Pfizer and Merck may help to reduce treatment shortages.

Tangent

Bebtelovimab was discovered by Vancouver-based biotechnology firm AbCellera, which examined antibodies from people who had recovered from Covid-19 to find which were most effective against the virus. AbCellera then provided the most promising antibodies—including bebtelovimab—to Eli Lilly, which is responsible for developing, manufacturing and distributing them. Because bebtelovimab targets a rarely mutated part of the spike protein, it may continue to work against future variants, AbCellera said.

Crucial Quote

“This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

Contra

Bebtelovimab is not authorized for patients hospitalized due to Covid-19 or requiring oxygen therapy due to the virus, the FDA said. Monoclonal antibodies like bebtelovimab may be associated with worse outcomes when given to hospitalized Covid patients requiring high-flow oxygen or mechanical ventilation, the agency said.