Eli Lilly's antibody bamlanivimab is discontinued in three U.S. states

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According to Endpoints News, Acting Commissioner Janet Woodcock of the U.

Woodcock did not elaborate on the virus mutation or the decision to stop drug distribution, but in general, the US FDA is still in a unique position to screen monoclonal drugs for different mutations.

An Eli Lilly spokesperson said in a statement: “We recognize that the U.

According to reports, Eli Lilly has been monitoring the changes in the virus and believes that bamlanivimab alone is effective in 75%-85% of US cases.

Previously, the US FDA had instructed Eli Lilly and its antibody development partner Regeneron to track virus mutations.

In the new emergency use authorization issued at the end of February and early March this year, the US FDA instructed these companies to monitor new mutations and may conduct studies to understand the effects of these drugs against viral changes.

Eli Lilly's bamlanivimab received an FDA emergency use authorization license in November 2020, and subsequently received a license for the combined use of bamlanivimab and etesevimab in February.

Recently, the combination drug combination also provided impressive research data, showing that early use in COVID-19 patients who are at high risk of serious illness can reduce hospitalization and mortality by 87%.

But in general, Woodcock believes that the initial monoclonal antibody drugs are “not the best” because they are centered on the distribution model of Gilead’s antiviral drug remdesivir, and the hospital has no capacity.

When talking about the development of monoclonal antibodies in the United States, Woodcock said: "We are making progress, but it will take a long time.

John Farley, director of the US FDA's Office of Infectious Diseases, said that the regulatory agency expects to soon expand its definition of who falls into the "high-risk" category, which determines who can receive monoclonal antibody treatment.

The three currently authorized monoclonal antibody drugs are still effective against virus mutations originating in the United Kingdom, but there are "other more worrying mutations", and doctors should be able to see more information about these mutations soon.

As for the broader treatment prospects of COVID-19, Woodcock once again pointed out that only 5% of COVID-19 treatment clinical trials have enough motivation and randomness to provide actionable data.

At the same time, Woodcock also introduced some of the main challenges she faces as the head of the "Operation Warp Speed" project therapeutics, and what the strong ecosystem of clinical trials in the United States will look like.

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