The US Food and Drug Administration (FDA) granted this Saturday, November 21, 2020, an emergency authorization to the biotechnology company Regeneron for the use in the country against the monoclonal antibody treatment covid-19 which received in October on US President Donald Trump to cure the disease.
The authorization restricts the use of the drug to people over the age of 12 who have tested positive for COVID-19 and who are at risk of developing a severe case of the disease, said FDA chief scientist Denise M Hinton, in a letter to the company.
The drug is a cocktail of two strong antibodies which in preliminary studies have shown promise in containing the infection, especially when given in the early stages of the disease.
The FDA already granted another emergency clearance earlier this month for the use in the country of a very similar cocktail owned by pharmaceutical company Eli Lilly. No treatment can be given to hospitalized people or to patients in need of oxygen.
Shortly after confirming that he tested positive for COVID-19 in early October, Trump was given an 8 gram dose of the Regeneron antibody cocktail, even though its use was not cleared by the FDA.
After overcoming covid-19, Trump claimed this treatment was primarily responsible for its improvement and defined it not as “therapy” but as “cure”, despite the fact that there have no scientific evidence to support this conclusion.
When requesting emergency clearance in October, Regeneron said that, once granted, the US government has “committed to making doses available to Americans free of charge and will be responsible for their distribution.”
The biopharmaceutical then said it had doses for 50,000 patients, but expected to have enough to treat 300,000 “in a few months”.
The emergency clearance comes on the same day the United States surpassed 12 million infections from the novel coronavirus and already adds more than 255,000 deaths, more than any other country in the world
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