Eli Lilly seeks emergency use autho for COVID antibody treatment
Eli Lilly and Co. has applied for an emergency use authorization for its experimental monoclonal antibody treatment for patients with COVID-19.
The drug giant reported positive data this week from a trial showing that its combination antibody therapy reduced the rate of hospitalizations in patients with mild-to-moderate symptoms to 1 percent — compared to 5.8 percent on a placebo. The 268-patient study also showed that the antibody treatments significantly lowered the virus load up to 11 days after being administered.
So far, the FDA has yet to issue an EUA to any of the monoclonal antibody treatments being tested on coronavirus patients. The agency has granted an EUA to Gilead’s remdesivir to treat patients with more severe symptoms. If approved, Lilly’s mAb would be the first EUA given to a therapy targeting patients with a milder case of the virus.
Lilly’s treatment, dubbed LY-CoV55, was developed using a blood sample from one of the earliest patients to survive COVID-19 in the U.S. Another two-antibody cocktail in testing that was developed by Regeneron was given to President Trump after he tested positive for the coronavirus.
Lilly reported that it can have 100,000 doses of the treatment manufactured by the end of this month and up to 1 million doses ready before the end of the year.
Read the full Wall Street Journal report.