FDA Grants Emergency Authorization to Regeneron Antibodies

In the ongoing battle against the coronavirus, the Food and Drug Administration (FDA) has granted emergency authorization to Regeneron for its antibody cocktail.

The experimental antibody treatment, called REGEN-COV2, is a cocktail of two powerful antibodies that have shown promising results in reducing the number of medical visits needed by COVID-19 patients who get the drug early in the course of their illness.

“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,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.

This antibody cocktail is the one given to President Donald Trump when he contracted the virus.

The company submitted its request for emergency authorization to the FDA shortly after President Trump tested positive for the virus and received Regeneron’s treatment.

The emergency authorization for the drug cocktail does have a limited scope. The drug can only be used on people who are 12 and over, who have already tested positive for the virus, and are at risk of developing severe coronavirus symptoms.

The authorization is limited to high-risk patients, such as those who are older than 65 years of age or have a BMI greater than or equal to 35. People who contract the virus who have other conditions like diabetes, cardiovascular disease, or chronic kidney disease also qualify for the drug.

“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 health care system. As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments,” said FDA Commissioner Stephen M. Hahn, M.D.

Unlike other drugs meant to aid in the treatment of coronavirus, the Regeneron drug is intended to be given early on after contracting COVID-19. Specifically, it is administered before patients are hospitalized or require oxygen therapy.

Regeneron’s antibody cocktail is a combination of two monoclonal antibodies known as casirivimab and imdevimab, which are both produced in a laboratory. These antibodies target the spike protein the coronavirus uses to drill into healthy cells. The goal of the antibodies is for them to trap and shut down the viral replication of the virus.

Production of the antibodies is time and labor-intensive according to Regeneron. However with the granting of authorization and the aid of the federal government through Operation Warp Speed, the company is set to roll out the cocktail by the end of November.

“Regeneron now expects to have treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021,” announced the company in a statement.

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