FDA grants emergency authorization to antibody drug for COVID-19 treatment

170 views
The US Food and Drug Administration (FDA) issued on Saturday evening an emergency use authorization (EUA) for an antibody cocktail made by Regeneron Pharmaceuticals.
The US Food and Drug Administration (FDA) issued on Saturday evening an emergency use authorization (EUA) for an antibody cocktail made by Regeneron Pharmaceuticals.

WASHINGTON — The US Food and Drug Administration (FDA) issued on Saturday evening an emergency use authorization (EUA) for an antibody cocktail made by Regeneron Pharmaceuticals that was used to treat US President Donald Trump when he was diagnosed with the coronavirus last month.

The FDA said in a statement this it issued an EAU for “the monoclonal antibodies casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age to older and weighing at least 40 kilograms) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.”

“This includes those who are 65 years of age or older or who have certain chronic medical conditions,” the statement added.

It affirmed that in clinical trials of patients with coronavirus, “casirivimab and imdevimab administered together have 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 treatment is part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies created by the human body to fight infections.

Regeneron's REGEN-COV2 "antibody cocktail" — containing an antibody made by the company and a second isolated from humans who recovered from COVID-19 — is designed so that the two antibodies seek out and bind to the coronavirus' spike protein to prevent it from entering healthy human cells.

Regeneron said on Saturday the clinical evidence from outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

The company said it expects to have REGEN-COV2 treatment doors ready for about 80,000 patients by the end of November, about 200,000 patients by the first week of January and approximately 300,000 patients in total by the end of January.

The FDA said the antibodies are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. — KUNA


170 views