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FDA grants emergency use authorization to Lilly's combination antibody therapy

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Posted at 11:04 PM, Feb 10, 2021
and last updated 2021-02-11 13:08:47-05

INDIANAPOLIS — The U.S. Food and Drug Administration has granted an emergency use authorization for Indianapolis-based Eli Lilly's combination COVID-19 antibody therapy.

According to the company, the therapy is a combination of two drugs — bamlanivimab and etesevimab — designed to be administered together in a single IV infusion. The emergency use authorization covers treatment of mild to moderate COVID-19 in patients ages 12 and older who are at risk of progressing to severe COVID-19 and/or hospitalization.

The FDA has also approved infusion times for the two drugs as short as 16 or 21 minutes, a reduction from the previously approved time of 60 minutes. The decision was based on feedback from front-line doctors and nurses administering the infusions, the company said.

"Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat COVID-19," Dr. Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories, said. "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."

A study has shown the combination of the two drugs can reduce the risk of hospitalization and death by 70 percent. It can also be used on patients at high risk for severe illness.

Lilly said it has 100,000 doses already available and they plan to make up to 1 million doses by the middle of the year.

"Every time we control the spread of the disease, every time we decrease the duration of the illness, every time we prevent someone from going to the hospital, we are and we will be doing a dent on the progression of this disease," Dr. Imad Shawa, of Franciscan Health, said. "Every single little win in that war will lead to a better outcome."