The US Food and Drug Administration (FDA) granted this Saturday an emergency authorization to the biotechnology 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.
(Read also: Those that lead in the race of vaccines against covid-19).
The authorization limits 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 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 if given during the early stages of the disease.
(Of your interest: The tragedy of Providencia, in the voice of its witnesses: fear, pain and faith).
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 needing oxygen.
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, despite the fact that its use was not authorized 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.
(In context: Drug against covid-19 that Trump took).
When he asked for the emergency authorization in October, Regeneron said that, once granted, the US government had “committed to making doses available to Americans at no cost and will be responsible for their distribution.”
Biopharmaceuticals then indicated that it had doses for 50,000 patientsbut he hoped to have enough available to treat 300,000 “in a few months”.
(Keep reading: Pfizer will request authorization to commercialize its covid-19 vaccine).
The emergency authorization arrives on the same day that the United States has exceeded 12 million infections of the new coronavirus and it already has more than 255,000 deaths, more than any other country in the world.
HEALTH AND EFE UNIT
*The article has been translated based on the content of Source link by https://www.eltiempo.com/salud/regeneron-farmaco-que-uso-trump-contra-la-covid-19-aprobado-por-la-fda-550395
. If there is any problem regarding the content, copyright, please leave a report below the article. We will try to process as quickly as possible to protect the rights of the author. Thank you very much!
*We just want readers to access information more quickly and easily with other multilingual content, instead of information only available in a certain language.
*We always respect the copyright of the content of the author and always include the original link of the source article.If the author disagrees, just leave the report below the article, the article will be edited or deleted at the request of the author. Thanks very much! Best regards!