US Food and Drug Administration (FDA) gave emergency approval to biotechnology company Regeneron this Saturday for use in the country against COVID-19 treatment with monoclonal antibodies that US President Donald Trump received in October to treat the disease.
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The authorization limits the use of the drug to people over 12 years of age who have tested positive for COVID-19 and are at risk of developing a severe case of the diseaseexplained Denise M. Hinton, the FDA’s chief scientist, in a letter sent to the company.
The drug is a cocktail of two powerful antibodies that have been tested in preliminary studies showed promising results in controlling infectionespecially if given in the early stages of the disease.
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Earlier this month, the FDA issued another emergency approval for domestic use of a very similar cocktail, owned by pharmaceutical company Eli Lilly. No treatment can be given to hospitalized people or patients needing oxygen.
Shortly after confirming that he tested positive for COVID-19 in early October, Trump was given an 8-gram dose of Regeneron’s antibody cocktaildespite the fact that its use has not been approved by the FDA.
After defeating COVID-19, Trump confirmed that this treatment was the main reason for his improvement and defined it not as “therapy” but as “cure”.despite the fact that there is no scientific evidence to support this conclusion.
(In the context of: The Covid-19 drug that Trump took).
When he applied for an urgent authorization in October, Regeneron said once it was granted, the US government “undertook to make the doses available to Americans free of charge and would be responsible for distributing them.”
Biopharmaceuticals he then indicated that he had doses for 50,000 patientsbut he hoped there would be enough to heal 300,000 “in a few months.”
(Read on: Pfizer will apply for approval to commercialize its COVID-19 vaccine).
Emergency approval arrives on the day United States surpassed 12 million infections with novel coronavirus and already has over 255,000 deaths, more than any other country in the world.
HEALTH AND EFE UNIT