US Food and Drug Administration (FDA) granted urgent authorization this Saturday to biotech company Regeneron for use in the country against covid-19 of the monoclonal antibody treatment that US President Donald Trump received in October to treat the disease.
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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 severe case of the diseaseexplained FDA Chief Scientist Denise M. Hinton in a letter to the company.
The drug is a cocktail of two powerful antibodies which, in preliminary studies, have shown promising results in the content of infection, especially if given in the early stages of the disease.
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The FDA has already issued another emergency approval earlier this month for the use of a very similar cocktail in the country, owned by the pharmaceutical company Eli Lily. Neither treatment can be administered to hospitalized persons or patients in need of oxygen.
Shortly after confirming that he had tested positive for covid-19 in early October, Trump received a dose of 8 grams of cocktail with Regeneron antibodies, despite the fact that its use was not authorized by the FDA.
After overcoming covid-19, Trump acknowledged that this treatment was primarily responsible for improving it and defined it not as “therapy” but as “medicine”., despite the fact that there is no scientific evidence to support that conclusion.
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When asked for emergency authorization in October, Regeneron said that once awarded, the US government “has committed itself to providing doses to the United States at no cost and will be responsible for their distribution.”
Biopharmaceutical products then indicated that there were doses for 50,000 patientsbut it is expected to have enough available to treat 300,000 “in a few months”.
(Continue reading: Pfizer will seek authorization to commercialize its covid-19 vaccine)
Emergency authorization comes on the same day that the United States surpassed 12 million new coronavirus infections. and there are already more than 255,000 deaths, more than any other country in the world.
HEALTH AND EFE UNIT