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FDA approves Regeneron antibody cocktail for COVID-19 treatment

November 23, 2020 | 07:49

Regeneron Pharmaceuticals Inc.’s antibody cocktail received an emergency use authorization from U.S. drug regulators for treatment of early Covid-19 symptoms, adding to the expanding arsenal of therapies available to physicians.

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Regeneron vaccine will be given to high-risk patients (Photo: Fierce Pharma)
Regeneron vaccine will be given to high-risk patients (Photo: Fierce Pharma)

The FDA said it's okay to give it to high-risk patients with mild or moderate symptoms.

The treatment, administered to President Donald Trump after he contracted the coronavirus in October, consists of two monoclonal antibodies that target the spike protein used by the virus to enter cells. Trump was treated with the drug based on a compassionate-use request by his doctors, Business Insider said.

In a clinical trial of patients with Covid-19, casirivimab and imdevimab, administered together, were shown to reduce Covid-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the FDA said.

Regeneron's chief executive officer, Dr. Leonard S. Schleifer, said in a statement that demand may initially exceed supply, "making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need."

The cocktail contains two antibodies produced in a lab, and can be given to patients who are newly infected. Regeneron submitted its application for the authorization in October, shortly after Trump tested positive for the coronavirus and received the biotechnology company's antibody therapy.

Regeneron says it will have doses ready for 80,000 patients this month, and enough for a half million more by the end of January, according to WKBW.

Regeneron said on Twitter an initial supply to treat about 300,000 patients would be allocated by the U.S. government.

Treatment is for use early in infection

According to CNN, unlike some other drugs used for Covid-19, the antibody cocktail is meant to be given early in infection, before patients are hospitalized or require oxygen therapy. The drug should be given as soon as possible after a positive viral test, according to the FDA.

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

The authorization only applies to patients 12 years of age or older. The cocktail has not been authorized for use in patients who are hospitalized with Covid-19 or need oxygen therapy because of Covid-19.

The antibody cocktail is meant to be given early in infection (Photo: Fox Business)
The antibody cocktail is meant to be given early in infection (Photo: Fox Business)

Regeneron's cocktail is a combination of two monoclonal antibodies, casirivimab and imdevimab, that are produced in a laboratory.

The antibodies target the spike protein the virus uses to drill into healthy cells. With two antibodies, the hope is to trap and shut down viral replication.

Regeneron isn't the only company that's been working on antibody therapies for the coronavirus. There are more than 70 different antibody treatments for Covid-19 under investigation, according to BIO, an association that represents major biotechnology companies.

Earlier this month, the FDA issued an emergency use authorization for another antibody treatment from pharmaceutical manufacturer Eli Lilly with similar conditions.

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