Eli Lilly asks FDA to authorize Kovid-19 antibody drug


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& Co. said it requested the US authorization of emergency use of an experimental antibody-based treatment for people with recently diagnosed, mild to moderate Kovid-19 following positive results from a clinical trial.

The Indianapolis-based company said it is seeking authorization for its drug, code LY-CoV555, taken from a blood sample of one of the earliest American survivors of Kovid-19.

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If cleaned, it may be the first country to treat less serious cases of Kovid-19. Some other treatments authorized Kovid-19 treatment, including Remedisvir from Gilead Sciences. Inc.

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Target hospitalized patients with more severe cases.

Lilly’s antibody drug Kovid-19 may be the first in a new class of agents that can not only provide treatment, but possibly provide temporary protection against the virus to people at risk of infection. A gap will be filled until vaccines are authorized.

Major experimental antibody drugs have so far shown substantial promise in testing that President Trump was developed by a Regeron pharmaceuticals Inc.

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

The Indianapolis company is building doses and may have 100,000 doses in this month and one million by the end of the year.

Antibody treatments are meant to mimic the human immune system’s own agents that can neutralize new coronoviruses.

The Lily antibody, LY-CoV555, comes from a collaboration between Lilly and Abellera Biologics Inc. of Vancouver, Canada. Abelera isolated antibodies from a blood sample taken from one of the first people in the US to recover from Kovid-19. Antibody therapy is essentially a clone of one of those antibodies.

In August, Lily began a study at a nursing home to test whether the LY-CoV555 facility could reduce the rate of infection and illness among vulnerable residents and staff after a case was diagnosed.

Lilly also stated that a new study showed that LY-CoV555 in Kovid-19 patients had lower viral load, symptoms, and hospitalization than another antibody. The rate of Covid-19-related hospitalizations and emergency room visits was 0.9%, compared to 5.8% in the placebo group.

The company hopes to seek an emergency-use authority for the combination in November.

The second antibody in combination therapy, LY-CoV016, came from a partnership with Junshi Biosciences,

Of China. Each antibody targets a different region of the spike protein that is found on the surface of the new coronovirus.

Previously: An increasing number of hospitals are investigating antibiotic testing and blood plasma therapy to combat new coronoviruses in sick patients. WSJ’s Daniela Hernández explains. Photo Illustration: Laura Kammran

The company is in discussions with regulators outside the US to potentially approve the use of its single and combination antibody therapy.

Lily said she hopes to make 50,000 doses of combination therapy this year, and that supply will increase significantly early next year. Lily recently formed a collaboration with Amgen Inc.

To help make antibodies, and Lily said on Wednesday that it would form additional partnerships to provide treatment to resource-limited countries.

Write Peter Loftus at [email protected]

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