United States granted this Saturday emergency approval for a treatment with synthetic antibodies against Covid-19 of the Regeneron company that was used to treat the president Donald Trump when he contracted the coronavirus.
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“Licensing these monoclonal antibody therapies can help outpatients avoid hospitalization and ease the burden on our healthcare system,” said Stephen Hahn, Commissioner of the US Food and Drug Administration (FDA, for its acronym in English).
The authorization limits the use of the drug to people over 12 years of age who have tested positive for the Covid-19 and are at risk of developing a severe case of the disease, FDA chief scientist Denise M. Hinton explained in a letter sent to the company.
The drug is a cocktail of two powerful antibodies that, in preliminary studies, have shown promising results in containing the infection, especially when given during the early stages of the disease.
The FDA already granted at the beginning of this month another emergency authorization for the use in the country of a very similar cocktail, owned by the pharmaceutical company Eli Lilly. Neither treatment can be given to hospitalized people or patients who need oxygen.
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Shortly after confirming that he had tested positive for Covid-19 in early October, Trump received an 8-gram dose of Regeneron’s antibody cocktail, even though its use was not cleared by the FDA.
After overcoming covid-19, Trump affirmed that this treatment was the main responsible for his improvement and defined it not as “therapy”, but as a “cure”, despite the fact that there is no scientific evidence to support that conclusion.
When he requested the emergency authorization in October, Regeneron said that, once granted, the US government had “committed to having doses available to Americans at no cost and will be responsible for their distribution.”
The biopharmaceutical company then indicated that it had doses for 50,000 patients, but expected to have enough available to treat 300,000 “in a few months.”
The emergency authorization comes on the same day that the United States has exceeded 12 million infections of the new coronavirus and already adds more than 255,000 deaths, more than any other country in the world.
agv / lsm