FDA Allows Emergency Use Of Antibody Drug Trump Received

22 Novembre, 2020, 12:38 | Auteur: Yves Courtet

A Covid-19 antibody therapy used to treat President Donald Trump was approved by the United States drug regulator on Saturday for people who aren't yet hospitalized by the disease but are at high risk. "Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system".

Tests of the drug are continuing, but early results suggest it may prevent hospitalization and emergency room visits. It is to note that the treatment has received an emergency approval for patients who have not been hospitalized yet but are at a high risk. To be sure, after any infection, the human immune system has the tendency to respond naturally against the infection, thus releasing antibodies.

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Use is allowed for adults and children 12 and over who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

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This compared to nine percent in placebo-treated patients.

"Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021", the company said in a news release Saturday. Its decision comes as US cases, hospitalizations and deaths all trend upward. The US has added more than 360,000 new Covid-19 cases in the past two days alone.

Regeneron has received more than $450 million from the U.S. government for its Covid-19 drug development efforts under Operation Warp Speed. The company in October applied to the FDA asking for emergency use authorization of its antibody treatment. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied.

Meanwhile, it is likely that Pfizer and Moderna, two pharmaceutical giants, will start distributing COVID-19 vaccines in the United States soon after they have reported more than 90 per cent efficacy in human clinical trials.

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