U.S. The Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals Inc.’s emergency-use for COVID-19 antibody therapy, an experimental treatment given to President Donald Trump that he said helped cure the disease.
The FDA said on Saturday that monoclonal antibodies, casirivimb and imdevib, should be administered together for the treatment of mild to moderate COVID-19 in adult and pediatric patients who are likely to develop severe forms of COVID-19.
This includes people who are 65 years of age or older or have a long medical condition.
“Authorizing these monoclonal antibody treatments can help outpatient hospitalization and relieve the burden on our health care system,” said FDA Commissioner Stephen Hayne.
The agency said antibodies are hospitalized for patients or not authorized for the need for oxygen therapy due to coronavirus.
C patients Cividib and Imdevim imab therapy have not been shown to be beneficial in patients who have had to be hospitalized due to COVD-19.
Emergency measures to move forward with its use are decided by assessing the potential risks and the balance of product benefits in a critical situation, the FDA said. It is not the same as FDA approval.
‘Important step’
The agency said data supporting Regiron’s Emergency Use Author Thoracicization came from clinical trials in 9999 non-hospitalized patients with ethical and moderate symptoms, including those with COVD-1.
From obesity to old age to diabetes – for patients at high risk due to a variety of underlying conditions – hospitalization and emergency room visits occurred in three percent of patients receiving intravenous treatment. This was compared to nine percent of patients treated for placebo.
Leonard Slaif, president and CEO of Regeneron, said FDA authorization is “an important step in the fight against COVID-19, as high-risk patients in the United States will receive promising treatment early in their infection.”
After Trump’s fight over coronavirus and treatment in October, he praised the antibody cocktail and said he wanted emergency approval for the drug.
“It simply came to our notice then. It made me feel better, right? I call it a cure, ”the president said.
He said, “I want to get what I got for you and I release it,” he added, “thousands of doses that are ready right now.”
A similar antibody treatment, developed by Ally Lilly, was also approved for emergency earlier this month.
According to the New York Times, Regeneron has received more than m 500 million from the US government to develop the treatment.
The first 300,000 doses will be provided free of charge by the government, but patients will have to pay for health facilities to administer the drugs, the drug manufacturer said in a statement.
But cases are on the rise across the United States and globally, which means that access will not be widespread. The USA has added more than 360,000 new COVID-19 cases in the last two days alone.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after authorization of emergency use.
In the case of COVID-19, Regener discovered the first two antibodies that were most effective against the SARS-CoV-2 virus, one from a rat whose immune system was altered to a human, the other from a human.
They then cut the immune cells that made those antibodies and grew them in a laboratory.
Covid-19 vaccines, like those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so that they are ready when they are exposed to the virus.
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