The U.S. Food and Drug Administration on Monday authorized emergency use of Eli Lilly's experimental Covid-19 antibody treatment for non-hospitalized patients older than 65 or who have certain chronic medical conditions.
The FDA said its emergency use authorization (EUA) was based on clinical trials showing that the treatment, bamlanivimab, reduced the need for hospitalization or emergency room visits in Covid-19 patients at high risk of disease progression.
It can now be used for treating mild-to-moderate Covid-19 in adults and pediatric patients over the age of 12, the FDA said.
The antibody is not authorized for patients who are hospitalized due to Covid-19 or require oxygen therapy due to Covid-19. The FDA said the drug, which U.S. President Donald Trump has praised, had not been shown to benefit such patients and could worsen their clinical status.
A U.S. government-sponsored study of the treatment in hospitalized Covid-19 patients was recently abandoned because the treatment was not shown to be helping.
In early October, Eli Lilly requested EUA for its single-antibody therapy. Results from a study of 452 patients with mild-to-moderate Covid-19 published in a peer-reviewed journal in late October found that 1.6% of those who got the antibody infusion had to be hospitalized or required an emergency room visit, compared with 6.3% of those who received a placebo.
The company has said it plans to pursue a similar authorization in November for its two-antibody cocktail, which it described as having helped reduce viral levels even more than the single-antibody treatment.
Both treatments are monoclonal antibodies – a widely used class of biotech drugs that are manufactured copies of antibodies created by the human body to fight infections.
Lilly expects to supply as many as one million doses of the single-antibody therapy in the fourth quarter, with 100,000 doses available in October. It struck a $1,250 per dose deal with the U.S. government and plans to sell to other countries.
Shares of the Indianapolis drugmaker, which closed little changed at $142.33 in regular trading, were up 3.6% after hours.
Several other drugmakers, including Regeneron Pharmaceuticals Inc, are testing antibody treatments for Covid-19.
Regeneron's antibody treatment was given to Trump after he caught the virus in early October. The nation's top infectious disease expert Dr. Anthony Fauci said it likely contributed to his recovery.