Regeneron Applies for Emergency Use Approval to FDA After Trump's Promising Treatment
Regeneron Pharmaceuticals, the biotech company that gave treatment to Pres. Trump on Friday, asks Emergency Use Authorization from the US FDA.
The Regeneron Pharmaceuticals has confirmed through its website that they applied for an Emergency Use Authorization to the U.S. FDA. The biotechnology company gave experimental monoclonal antibody therapy to Pres. Trump on Friday when he was diagnosed with COVID-19.
They wrote on their website: "Under our agreement with the U.S. government for the initial doses of REGN-COV2, if the EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution."
In addition to that, the company also claimed that at the moment, they have doses available for approximately 50,000 patients and they expect to have doses available to 300,000 patients in the next few months.
As of now, no details have been released yet as to how the recipients will be selected.
Regeneron's treatment given on individual basis
According to a published article in CNN News, Regeneron's experimental antibody treatment is still in large-scale human clinical trials.
However, it has been available for compassionate use and can only be used on an individual basis through the approval of the FDA. The same as what they did when they use the treatment for Pres. Trump after he tested positive for COVID-19.
In a statement released by the Regeneron, the biotechnology company said that the antibody therapy is a combination of two monoclonal antibodies that are designed specifically to block the infectivity of the virus that is responsible for COVID-19.
Regeneron CEO Dr. Leonard Schleifer was quoted as saying, "When you weigh the potential benefit versus the risks, the downsides are very low here because we have not seen any safety concerns."
Schleifer made this statement after he gave an eight-gram dose of treatment to Pres. Trump.
According to the data that the company released, the treatment worked fairly with few side effects. Dr. Leonard Schleifer even said, "This class of drugs is an extremely safe class."
Divided reaction to Regeneron's treatment
The treatment was both embraced and criticized.
Former acting director of the U.S. Centers for Disease Control and Prevention Dr. Richard Besser said that it is good to hear that the treatment of Regeneron gives a patient antibodies that would help improve the immune system.
However, he also asserted that there is a need for a peer review to know the holes or pitfalls.
Dr. Besser said, "You know these early results that keep coming out from companies in press releases strike me as being... much more about the stock price than they are about science."
He also added that he would withhold judgment on the treatment until he sees more data.
Meanwhile, former CDC Director Dr. Thomas Frieden disagreed with Dr. Besser. He said that even though Regeneron's antibody therapy is unproven, he firmly believed that the treatment is promising.
Dr. Frieden explained, "There's a report that only fewer than 300 patients have received it. "It seems to be most effective early in the disease, especially before patients make antibodies of their own."
Check this out!
- "Plain Truths" About COVID-19 from Former CDC Director
- COVID-19 Outbreak in White House as 34 Staff Test Positive for Coronavirus
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