U.S., Lilly strike deal for potential COVID-19 antibody drug

On Monday, U.S. government officials announced they are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalized with COVID-19 because it doesn't seem to help. In the study, a very high dose of Lilly's antibody was used, yet there was no indication that it was effective.

In addition, Reuters reported that US drug inspectors uncovered serious quality control problems at an Eli Lilly plant that is ramping up to make its antibody therapy. There are also questions about the company's facilities.

It belongs to a class of drugs called monoclonal antibodies that are man-made copies of antibodies created by the body to fight against an infection.

ACTIV-3 was testing a high-dose version of the antibody treatment Lilly is developing with Canadian biotech AbCellera Biologics Inc.in combination with the antiviral drug remdesivir.

That is the same compound treatment President Trump received after contracting the coronavirus.

Overall, patients in the antibody group saw 99.97 percent of their viral loads eliminated compared to those who were given a placebo.

At the same time, Lilly signed an agreement with the United States government to deliver 300,000 doses of the antibody, for which it is being paid $375 million. After that, U.S. Department of Health and Human Services said the government has an option to buy an additional 650,000 vials for more than $800 million.

The price per dose amounts to $1,250 as per the contract, but the vials purchased by the government will be free to the American public. The trial was suspended October 13 out of "an abundance of caution", but the NIH said Monday it had found no significant safety issue with the monoclonal antibody treatment. Independent monitors had paused enrolment in the study two weeks ago because of a possible safety issue.

But on Monday, the National Institutes of Health, which sponsored the trial, found the drug posed no significant safety risks for patients.

In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness.



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