Eli Lilly Asks FDA to Authorize Covid-19 Antibody Drug


Eli Lilly & Co. said it has requested U.S. authorization of the emergency use of an experimental antibody-based treatment for people with recently diagnosed, mild-to-moderate Covid-19, following positive results from clinical testing.

The Indianapolis-based company said it is seeking the authorization for its drug, code named LY-CoV555, which was derived from a blood sample of one of the earliest U.S. survivors of Covid-19.

If cleared, it could be the first to treat less severe cases of Covid-19. The few other therapies authorized for Covid-19 treatment, including remdesivir from Gilead Sciences Inc., target hospitalized patients with more serious cases.

Lilly’s antibody drug could also be the first in a new class of Covid-19 agents that could not only provide treatment but also potentially give temporary protection against the virus to people at risk of infection. That would fill a gap until vaccines are authorized.

The leading experimental antibody drugs have shown enough promise in testing so far that President Trump was given one developed by Regeneron Pharmaceuticals Inc.

Lilly said last month its drug reduced the rate of hospitalization compared with a placebo in a study.

The Indianapolis company is manufacturing doses and could have 100,000 doses this month and as many as one million by the end of the year.

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