Regeneron’s COVID-19 Antibody Cocktail earns FDA Authorization
Overview
On Saturday, November 21st, Regeneron announced that the company’s Antibody Cocktail (casirivimab and imdevimab) for COVID-19 was approved for Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). Regeneron’s Antibody Cocktail has had previous time in the press for its role in President Donald Trump’s COVID-19 treatment. As the globe progresses towards a vaccine, medicine still doesn’t have reliable treatments for COVID-19. This article will outline the basics of the Antibody Cocktail, who’s eligible to receive the treatment, and potential outcomes from the FDA’s ruling.
About the Antibody Cocktail
The Antibody Cocktail is a drug designed to imitate the body’s natural response to fighting an infection. The drug contains two types of antibodies (casirivimab and imdevimab) administered together that interact with the spike protein found on the surface of SARS-CoV-2. Read CScreener’s article about Immunity to learn about the role that antibodies play in fighting infections.
Although the drug is still under clinical trials, Regeneron received sufficient data to propose an EUA to the FDA. Similar to COVID-19 vaccines, more data will become apparent as time moves forward such as long-term effects and the capacity to prevent COVID-19 infections. Regeneron’s Antibody Cocktail is one of few drugs approved by the FDA to treat COVID-19 and, yet, only proves to be effective for a select group of infected individuals.
Who’s Eligible?
In the EUA for casirivimab and imdevimab, the drug is specifically outlined for use on adult patients with mild to moderate symptoms and pediatric patients who have tested positive and are at risk of developing severe COVID-19 and/or hospitalization.
The EUA does not authorize use for certain patients who’ve developed more severe COVID-19. Specifically, patients who’ve been hospitalized, require oxygen therapy, or require an increased amount of oxygen from the baseline due to non-COVID-19 comorbidities.
What Does This Mean?
Reduced Number of Medical Visits: Throughout clinical trials, Regeneron’s Antibody Cocktail has shown to reduce the number of times infected individuals had to visit the emergency room. Data supports the drug being administered to individuals after diagnosis, but before symptoms begin developing and becoming more severe. In fact, treatment with monoclonal antibodies can result in worse clinical outcomes for patients receiving supplemental oxygen.
As the world focuses on a COVID-19 vaccine, it’s important to continue researching treatments and fighting for patients who are currently hospitalized with severe COVID-19.
Increased Production: Since the Authorization, Regeneron expects to produce enough doses for 80,000 patients by the end of November. By the first week of January, approximately 200,000 doses will be ready for patients and 300,000 by the end of January. Moreover, through Operation Warp Speed, the Antibody Cocktail will be used at no cost to patients
Impact on Viral Spread: When the drug goes into mass effect, it’s unknown whether the spread of SARS-CoV-2 will be altered. First, the antibody cocktail is known to reduce the number of viral particles in an infected individual, potentially shortening the time period in which they are infectious. However, if symptoms are reduced, these individuals might be more likely to enter public spaces and interact with others. In order to continue preventing the spread of SARS-CoV-2, infected individuals must be encouraged to maintain proper preventative habits.
Impact on Death Rate: Similar to viral spread, it’s not well known whether the death rate will be altered. The drug can reduce the number of hospital visits for patients with moderate symptoms. However, those patients are unlikely to develop severe COVID-19 that results in death. Moreover, the patients at the highest risk for death are unable to receive the treatment.
The clearest path to decreasing death rate seems to be administering the treatment following a positive antigen test and before symptoms reach a severe level.
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