Regeneron Licensed to Use Monoclonal Antibody Treatment in the US – Observer



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The US regulator granted this Saturday urgent authorization to the biotechnology company Regeneron for its use in the country of the treatment with monoclonal antibodies that the US president received in October against Covid-19.

Authorization from the United States Food and Drug Administration (FDA) limits the use of the drug to people over the age of 12 who have tested positive for Covid-19 and are at risk of developing a drug. severe case of the disease, explained FDA chief scientist Denise M. Hinton in a letter sent to the company.

The drug contains two powerful antibodies that, in preliminary studies, have shown promising results in containing the infection, especially if administered during the early stages of the disease.

The FDA earlier this month granted another emergency approval for nationwide use of a very similar ‘cocktail’ owned by the drug company Eli Lilly.

Neither treatment can be given to hospitalized people or patients who need oxygen.

Shortly after confirming that he tested positive for Covid-19 in early October, Trump received an eight-gram dose of the Regeneron antibody cocktail, even though the FDA had not approved its use.

After recovering, Trump said the treatment was primarily responsible for his improvement and defined it not as “therapy” but as “cure,” although there is no scientific evidence to support that conclusion.

When he applied for emergency authorization in October, Regeneron said that once granted, the US government had “committed to making the doses available to Americans for free” and would be responsible for distributing them.

The emergency authorization comes on the same day that the United States has exceeded 12 million infected with the new coronavirus and already has more than 255,000 deaths, more than any other country in the world.

The Covid-19 pandemic caused at least 1,373,381 deaths as a result of more than 57.5 million cases of infection worldwide, according to a report by the France-Presse (AFP) news agency.

The disease is transmitted by a new coronavirus detected at the end of December 2019 in Wuhan, a city in central China.

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