Eli Lilly (LLY -0.36%) received an emergency use authorization from the Food and Drug Administration for its COVID-19 treatment, bamlanivimab, on Monday afternoon. The drug is a therapeutic antibody designed to bind to the novel coronavirus that causes COVID-19.
The authorization covers patients aged 12 or older who have mild to moderate COVID-19, are at high risk for progressing to severe COVID-19, and might require hospitalization. The FDA would like patients treated as soon as possible after a positive COVID-19 test and certainly within 10 days of the onset of symptoms. The short time frame is going to make it somewhat difficult for doctors to determine which patients are most likely to progress to severe disease.
Eli Lilly has sold 300,000 doses of bamlanivimab to the U.S. government, which will be responsible for distributing the drug. Patients only get a single dose, so the stockpile can help 300,000 patients. Of course, the U.S. has been consistently reporting more than 100,000 COVID-19 cases per day lately, so the initial doses won't last too long.
The pharma giant expects to be able to manufacture up to 1 million doses by the end of 2020. Additional manufacturing capacity is expected to come on line throughout next year, resulting in increased production starting in the first quarter of 2021.
In addition to treating patients who have already developed COVID-19, Eli Lilly is also testing bamlanivimab as a preventative medicine in residents and staff at long-term care facilities. The drug is also being tested in a cocktail with a second antibody targeting the coronavirus as a treatment for COVID-19.