FDA Grants Eli Lilly’s Experimental COVID-19 Antibody-Drug Emergency Use Authorization

February 10, 2021 Updated: February 10, 2021

Eli Lilly’s COVID-19 antibody-drug has been granted emergency use authorization by the Food and Drug Administration (FDA), widening access to a therapy that has shown improvement in treating patients with mild to moderate cases of the CCP virus.

Data from a late-stage trial last month showed that Eli Lilly’s combination therapy of two antibodies, bamlanivimab and etesevimab, helped cut the risk of hospitalization and death in COVID-19, the disease caused by the CCP (Chinese Communist Party) virus, in patients by 70 percent.

The therapy will be available immediately, the Indianapolis-based pharmaceutical company said.

U.S. drug regulators previously granted emergency use authorization to a treatment from Eli Lilly that just used bamlanivimab. Former President Donald Trump received a similar treatment developed by Regeneron Pharmaceuticals after he tested positive for COVID-19 in October 2020.

“Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic,” Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA said in a release that while bamlanivimab and etesevimab administered together resulted in a lower risk of resistant viruses developing during treatment compared with bamlanivimab administered alone, both treatments are expected to benefit patients at high risk of disease progression.

The headquarters of the U.S. Food and Drug Administration
The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Md., on Nov. 4, 2009. (Jason Reed/File Photo/Reuters)

Eli Lilly said in a statement that 100,000 doses of its antibody-drug will be ready immediately and an additional 150,000 doses will be available throughout the first quarter of the year. It will also work with Amgen to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by the middle of the year.

The “therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization,” the company said.

“Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat COVID-19,” said Daniel Skovronsky, Eli Lilly’s chief scientific officer. “Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.”

Skovronsky added, “With the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world.”

Reuters contributed to this report.