Regeneron COVID-19 drug given to Trump gets FDA approval

The president acknowledged the benefits of antibody treatment that helped him recover after being hospitalized with the coronavirus.

Washington — The experimental treatment given while President Donald Trump was hospitalized at COVID-19 was granted an emergency permit by the Food and Drug Administration.

According to Johns Hopkins University, the FDA announced Saturday at Regeneron Pharmaceuticals Inc, just as the number of confirmed cases of coronavirus in the United States reached 12 million. Said that the authorization was issued.

Regeneron antibody therapy may be effective in treating patients with mild or moderate COVID-19. It is two medicines called Casilibimab and Imdebimab, which are infused together by intravenous (IV) infusion.

“In clinical trials of COVID-19 patients, co-administration of casilibimab and imdebimab resulted in COVID-19-related hospitalization or emergency room in patients at increased risk of disease progression within 28 days of treatment compared to placebo. It has been shown that visits will be reduced, “the FDA said in a statement. “The safety and efficacy of this investigational drug for use in the treatment of COVID-19 continues to be evaluated.”

This treatment is not permitted for patients admitted for COVID-19 or who require oxygen therapy.

Related: The United States has passed 12 million COVID-19 cases, with approximately 200,000 recorded on Friday.

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Related: Donald Trump Jr. is positive for coronavirus

“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and reduce the burden on our healthcare system,” said FDA Commissioner Dr. Stephen Hahn.

According to the FDA, Casilibimab and Imdebimab are laboratory-made antibodies specifically directed against the coronavirus spike protein. They are designed to prevent the attachment of viruses and their invasion of human cells.

Urgent approval is different from FDA approval, federal agencies say. The FDA states that the benefits of antibodies have been found to outweigh the risks of treating patients with coronavirus. There are no suitable, approved and available alternative therapies for casilibimab and imdebimab.

After being infected in early October, Trump spent three days at Walter Reed Military Hospital in Maryland, receiving a variety of experimental treatments, including antibody therapy from Regeneron. Trump later admitted experimental medications that helped him recover.

Trump was treated for Regeneron through an exemption from “compassionate use,” a perception that goes beyond the standard care he received as president.

Contributed by The Associated Press.

Regeneron COVID-19 drug given to Trump gets FDA approval

Source link Regeneron COVID-19 drug given to Trump gets FDA approval

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