Saturday, 15 May, 2021

U.S. approves Regeneron antibody treatment given to Trump

US drug agency grants emergency use authorisation to antibody therapy given to Donald Trump Ben Carson Says He Was 'Desperately Ill' With The Coronavirus
Deanna Wagner | 22 November, 2020, 18:48

Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need.

FDA granted an emergency authorization for the drug, called REGN-COV2, to be used in people with the coronavirus who are at high risk of developing a severe case of the disease, but not for people who are hospitalised or who need oxygen. In issuing an EUA, the FDA evaluates the available scientific evidence and balances the potential risks with benefits of the product.

Regeneron submitted its application for the authorization in October, shortly after Trump tested positive for the coronavirus and received the biotechnology company's antibody therapy.

Regeneron is set to have doses ready for 80,000 patients by the end of this month and come January 2021, around 3 lakh patients can be given doses for these.

Leonard S Schleifer, President and CEO of Regeneron, said: "This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection". The drug should be given as soon as possible after a positive viral test, according to the FDA. It is to note that the treatment has received an emergency approval for patients who have not been hospitalized yet but are at a high risk.

"Data from approximately 800 non-hospitalized patients showed significant reductions in virus levels within days of receiving REGEN-COV2, which were associated with significantly fewer medical visits".

German prosecutors say there's evidence of cannibalism in Berlin man's murder
But Steltner said Friday that this case is different in that there are "no indications that the victim consented in any way". Like arresting a suspect in the Berlin murder case, Mewis was quick to talk to prosecutors and share his emotional details.

At the time of his diagnosis, Carson's office said he was in good spirits, but in a new Facebook post the 69-year-old HUD secretary said he was "extremely sick" before he took the herbal remedy Oleander 4X and saw his condition improve.

Covid-19 vaccines, like those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so they are prepared when they encounter the virus.

The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective.

"The FDA remains committed to advancing the nation's public health during this unprecedented pandemic". "Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system".

Regeneron isn't the only company that's been working on antibody therapies for the coronavirus.

Under the Emergency Use Authorisation, the recommended dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg total) administered as a single intravenous infusion.