FDA clears Regeneron Antibody Cocktail to treat Covid-19

The Food and Drug Administration Saturday issued a emergency use authorization in Regeneron for its 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, are antibodies created from a single cell and cloned in a laboratory. They are based on antibodies naturally created by the body’s immune system, although they are often modified for 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 the attachment and entry of the virus into human cells.

In its clearance, the FDA said that Regeneron treatment could be used to treat mild to moderate covid-19 in adults and children 12 years and older (with a weight of at least 88 pounds) which are at high risk of developing case of the disease. VSAsirivimab and imdevimab should be administered together by IV infusion.

FDA said it based its decision to issue emergency clearance for processing on the data of a randomized, double-blind, placebo-controlled clinical trial involving 799 patients. The patients were not hospitalized and presented with mild to moderate symptoms of covid-19. It is worth noting that Regeneron’s most famous patient is President Donald Trump, who received the cocktail soon after diagnostic with the disease after months of reckless behavior.

In the clinical trial, patients were divided into three groups. A group of 266 people received 2400 milligrams of the cocktail; another group out of 267 received 8000 mg of a cocktail; and one the third group of 266 received a placebo. Treatment was given within three days of receiving a positive covid-19t. According to the FDA, the reduction in viral load in patients receiving the cocktail was greater than those receiving the placebo on seventh day. The agency stressed, however, that the most important the evidence that suggests the cocktail might be effective was the result 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.

Dr Stephen Hahn, the commissioner of the FDA, 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 linked to covid-19, the United States broke its record of hospitalized patients with covid-19 for the 12th consecutive day, per 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 the Assessment and Research of FDA drugs, in a 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 to Eli lilly for bamlanivimab, which also targets the SARS-CoV-2 spike protein. In this authorization he cited an interim analysis of a clinical test in which patients receiving treatment saw a reduction in hospitalizations and emergency room visits.

However, the Regeneron antibody cocktail is not for everyone. Its use is not authorized in hospitalized patients; require oxygen therapy due to covid-19; or use chronic oxygen therapy due to an underlying comorbidity that require an increase in basal 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 on high-flow oxygen or mechanical ventilation due to covid-19.

Regeneron received hundreds of millions of dollars from the US government to the development and manufacture of its treatment. As a member of agreement, the company aims to provide the government with treatment for about 300,000 patients – which will be administered free of charge to patients, although healthcare facilities may charge an administrative fee – by the end of January.

There is a big problem, however. According to Centers for Disaster Control and Prevention, the 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 the progress of science, let us too do our part at stop the spread.