US FDA Grants Emergency Use Authorization for Eli Lilly's Antibody Treatment for Mild Patients

For those aged 65 and over not hospitalized or under 12... "Securing capacity for 1 million people this year"

[Image source=AP Yonhap News]

[Asia Economy Reporter Jeong Hyunjin] The U.S. Food and Drug Administration (FDA) on the 9th (local time) granted emergency use authorization for a novel coronavirus (COVID-19) antibody treatment developed by the U.S. pharmaceutical company Eli Lilly to be used for patients with mild symptoms.

According to Bloomberg News and others, the FDA approved the use of the monoclonal antibody treatment 'LY-CoV555,' developed jointly by Eli Lilly and the Canadian biotechnology company AbCellera. It can be administered to patients who are not hospitalized but are at high risk of becoming severe cases due to age?such as those aged 65 or older or 12 or younger?or other factors.

Clinical trial results submitted by Eli Lilly confirmed that a single dose of this antibody treatment reduces the need for hospitalization or emergency room visits among high-risk COVID-19 patients. Eli Lilly explained that the treatment must be administered as soon as possible after diagnosis and within 10 days from the onset of symptoms to be effective.

This emergency use authorization was granted about a month after the application was submitted on the 7th. The treatment was created by extracting antibodies from the blood of recovered COVID-19 patients, and last month, phase 3 clinical trials were temporarily halted due to safety concerns.

The U.S. government agreed on the 28th of last month to purchase 300,000 doses of Lilly's antibody treatment for $375 million. The initial contract covers delivery within two months after regulatory approval. Subsequently, an additional $812.5 million will be invested to purchase 650,000 more doses by June next year. Eli Lilly stated that it expects to secure enough doses to treat up to 1 million people by the end of this year.

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