The drug is a cocktail of two powerful antibodies that, in preliminary studies, have shown promising results from the content of the infection, especially if given in the early stages of the disease.
The US Food and Drug Administration (FDA) granted emergency authorization this Saturday 21-N to the biotechnology company Regeneron for use in the country against covid-19 the treatment with monoclonal antibodies it received in December October. US President Donald Trump to treat 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 are at risk of developing a serious case of the disease, explained chief FDA scientist Denise M. Hinton in and a letter sent to the company.
The drug is a cocktail of two powerful antibodies that, in preliminary studies, have shown promising results from the content of the infection, especially when given in the early stages of the disease.
The FDA has already granted another urgent authorization at the beginning of this month to use a very similar cocktail in the country, owned by the pharmaceutical company Eli Lilly. Neither hospital treatment nor patients requiring oxygen can be treated.
Shortly after confirming that he had tested positive for COVID-19 in early October, Trump received an 8-gram dose of Regeneron antibody cocktail, though his use was not cleared by the FDA.
After overcoming covid-19, Trump confirmed that this treatment was primarily responsible for its cure and defined not as “therapy”, but as “cure”, despite the fact that there is no scientific evidence to support the conclusion that.
When asked about the emergency authorization in October, Regeneron said that once granted, the US government is “committed to making doses available to Americans at no cost and that they will be responsible for dispensing them.”
The biopharmaceutical then stated 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 the same day that the United States has surpassed 12 million new coronavirus infections and is already adding more than 255,000 deaths, more than any other country in the world.