United States: Marketing Authorization Application for Anti-Covid Antibody Treatment

The American pharmaceutical company Eli Lilly announced Wednesday that it had filed an emergency authorization request for treatment with synthetic antibodies against Covid-19, in the same category as the drug injected into President Donald Trump last week.

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Mr Trump, infected with the coronavirus, received treatment from another company, Regeneron, which it has not yet applied for for approval and is continuing clinical trials. This route is considered promising for stopping the coronavirus in the initial stages of infection.

“Our teams have worked tirelessly for the past seven months to discover and develop these potential antibody treatments,” said Eli Lilly Scientific Director Daniel Skovronsky. “Lilly is working diligently with regulators around the world to make these treatments available.”

The treatment is based on antibodies specifically adapted for the neutralization of the coronavirus.

According to the group, a clinical trial on 268 patients suffering from mild or moderate forms of Covid-19, with placebo, showed that a cocktail of two types of antibodies:

– reduced viral load (3% of patients had a high viral load on the 7th day of illness, compared to 21% in the placebo group);

– reduced symptoms from the third day after injection;

– reduced the rate of hospitalizations and emergency room visits (0.9% versus 5.8% in the placebo group).

The group has requested authorization for only one type of antibody at this point.

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The American Medicines Agency (FDA) will have to study the data, and in particular the possible side effects, to decide whether or not to authorize the marketing of the treatment, and under what conditions.

The results were not published in a peer-reviewed scientific journal, which would have allowed the methodology to be independently validated.

The clinical trial is continuing and the company wants to recruit a total of 800 participants.

100,000 doses of the monotherapy (a single antibody) will be available in October, and a million by the end of the year, according to Lilly, as well as 50,000 doses of the two-antibody cocktail by the end of the year. year.

Antibodies are proteins in the immune system that fight infection. They are present and can be taken from the blood of recovered patients, but the natural antibodies thus recovered cannot be used for large-scale treatments.


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