The Food and Drug Administration Saturday issued a emergency use authorization a Regeneron for their cocktail of covid-19 monoclonal antibodies, which is composed of the antibodies casirivimab and imdevimab, citing reduced hospitalizations and emergency room visits among patients in a clinical trial as well as a reduction in viral load.
Monoclonal antibodies, which are used to treat other conditions such as Cancer or autoimmune diseases, These are antibodies created from a single cell and cloned in the laboratory. They are based on antibodies created naturally by the body’s immune system, although they are often modified for reasons of effectiveness and safety. In this case, the casirivimab and imdevimab cocktail is directed against the spike protein in SARS-CoV-2 and is designed to block binding and entry of the virus into human cells.
IAfter clearance, FDA said Regeneron treatment could be used to treat mild to moderate COVID-19 in adults and children 12 years and older (weighing at least 88 pounds) which are at high risk of developing serious illness case of the disease. VSasirivimab and imdevimab should be administered together by intravenous infusion.
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The FDA said it based its decision to issue emergency clearance for processing on the data since a randomized, double-blind, placebo-controlled clinical trial involving 799 patients. The patients were not hospitalized and had mild to moderate symptoms of COVID-19. It is to highlight that Regeneron’s most famous patient is President Donald Trump, who received the cocktail soon after being diagnostic with the disease after months of reckless behavior.
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In the clinical trial, patients were divided into three groups. A group of 266 people gave 2400 milligrams of the cocktail; another group 267 received 8000 mg of the cocktail; and one the third group of 266 received a placebo. Treatment was administered within three days of receiving a positive COVID-19 test.t. According to the FDA, the reduction in viral load in patients who received the cocktail was greater than in those who received the placebo in Seventh day. The agency stressed, however, that the most important The result suggested that the cocktail might be effective hospital and emergency room visits within 28 days treatment.
On average, only 3% of patients at high risk of severe disease who received the cocktail went to the hospital or emergency room within that time frame, the FDA said, versus 9% of patients treated with placebo. The effects on viral load and reduction in hospitalizations and emergency room visits were similar for patients who received either dose.
FDA Commissioner Dr Stephen Hahn said in a statement announce the authorization that monoclonal antibody therapies can help ambulatory patients avoid hospitalization and ease the burden on the country’s healthcare system. On Saturday, with at least 83,227 new hospitalizations for covid-19, the United States broke its record of hospitalized patients with covid-19 for the twelfth day in a row, according to CNN.
Others have pointed out that medical professionals have yet another tool to use against the virus.
“The emergency authorization of these monoclonal antibodies administered together offers healthcare providers another tool in the fight against the pandemic,” said Dr Patrizia Cavazzoni, Acting Director of the Center for Clinical Assessment and Research. declaration. “We will continue to facilitate the development, evaluation and availability of covid-19 therapies “.
The Regeneron antibody cocktail is the second monoclonal antibody treatment to receive FDA clearance this month. Almost two weeks ago the agency issued an emergency use authorization for Eli lilly para bamlanivimab, which also targets the SARS-CoV-2 spike protein. In this authorization, cited an interim analysis of a clinical test in which patients who received treatment saw a reduction in hospital admissions and emergency room visits.
However, the Regeneron antibody cocktail is not for everyone. It is not licensed for use in hospital patients; require oxygen therapy due to covid-19; or use chronic oxygen therapy due to an underlying comorbidity requiring an increase in baseline oxygen flow due to COVID-19, the company said in a Press release.
In fact, Regeneron found that hospital patients had not benefited from its cocktail.. He added that monoclonal antibodies may be associated with worse clinical outcomes when given to hospital patients with high oxygen flow or mechanical ventilation due to COVID-19.
Regeneron received hundreds of millions of dollars the United States government to develop and manufacture your treatment. As a member of agreementThe company aims to provide the government with treatment for around 300,000 patients – which will be provided to patients free of charge, although health centers may charge an administrative fee – by the end of January.
However, there is a big problem. According to Centers for Disaster Control and PreventionThe United States has reported about 1.1 million new cases in the past seven days. While having another tool to use in the pandemic is good news, it won’t be of much use if we continue to break records of cases and hospitalizations. As we marvel at advances in science, we do our part a stop the spread.
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