U.S. approves first COVID-19 antibody treatment
The U.S. Food and Drug Administration (FDA) on Monday (November 9) granted the emergency use of the first experimental antibody treatment for COVID-19.
Eli Lilly's bamlanivimab is a monoclonal antibody, or a synthetic copy of an antibody used by the immune system to fight infection.
The U.S. government has purchased 300,000 doses of the drug, which the company said it will begin shipping immediately.
There will be no out-of-pocket costs for patients, according to U.S. officials, although healthcare facilities may charge an administration fee.
Trial data showed that a one-time infusion of Eli Lilly's treatment reduced the need for hospitalization or emergency room visits in high-risk COVID-19 patients.
U.S. regulators have authorized Eli Lilly's treatment for patients who have been recently diagnosed with mild-to-moderate COVID-19 over the age of 65 and for patients 12 and older who have an underlying health condition.
The treatment will not be used on patients already hospitalized or who require oxygen therapy, as a U.S. government-sponsored study found it could worsen the clinical outcome in these cases.
In an emailed statement, The White House hailed the FDA's decision as "a major milestone."
U.S. President Donald Trump received a similar treatment created by Regeneron after he was diagnosed with the coronavirus in early October.
Regeneron is currently seeking emergency approval for a dual-antibody against COVID-19.
Meanwhile, Eli Lilly anticipates manufacturing up to one million doses of bamlanivimab by the end of 2020, for use around the world through early next year.
