Eli Lilly Covid Antibody Drug Gets Emergency FDA Clearance

Eli Lilly Covid Antibody Drug Gets Emergency FDA Clearance Eli Lilly & Co.’s antibody therapy was granted an emergency-use authorization by U.S. drug regulators for treating Covid-19, widening access to a treatment that early data suggests is effective in keeping people infected with the coronavirus out of the hospital. Riley Griffin Bloomberg.com

Eli Lilly & Co.’s antibody therapy was granted an emergency-use authorization by U.S. drug regulators for treating Covid-19, widening access to a treatment that early data suggests is effective in keeping people infected with the coronavirus out of the hospital. ...

The Food and Drug Administration authorized the experimental treatment, called bamlanivimab, for use against mild-to-moderate Covid-19 in adults, including those who are 65 and older, and pediatric patients, the agency said on its website.

The clearance gives doctors an option for tackling the virus in high-risk patients before they’re sick enough to require hospitalization. Other treatments that received the regulatory go-ahead, such as convalescent plasma, a component collected from the blood of recovered Covid patients containing immune factors, and Gilead Sciences Inc.’s antiviral remdesivir, are intended for use in severely ill Covid-19 patients.

Now begins an even more difficult challenge: distribution. Lilly said in a statement Monday that bamlanivimab should be administered “as soon as possible after a positive Covid-19 test and within 10 days of symptom onset.” Lilly will begin shipping the antibody therapy immediately to AmerisourceBergen Corp., which will distribute it as directed by the U.S. government. Americans will have no out-of-pocket costs for the medicine, the company said, while acknowledging that health-care facilities may charge a fee for the product’s intravenous administration.

Experimental antibody treatments could become a powerful component of the arsenal that doctors use to treat the coronavirus. Anthony Fauci, the top U.S. infectious-disease official, has referred to antibody-based medicines as a bridge to a vaccine. The class of treatments was thrust into the spotlight after President Donald Trump received an antibody made by Regeneron Pharmaceuticals Inc. after becoming infected with Covid-19. ...