Regeneron’s COVID-19 Antibody Drug for Injections Authorized by FDA

Regeneron Pharmaceuticals Inc.’s COVID-19 antibody drug for injections has been greenlighted by the U.S. Food and Drug Administration (FDA) on Friday, who updated the emergency use authorization for REGEN-COV lowering the dose from 2,400 mg to 1,200 mg, Reuters reports.

The authorization also says the doctors and nurses can now administer one of the new, more convenient forms of the drug by intravenous infusion or subcutaneous injection when an infusion is not feasible.

FDA authorized Regeneron’s monoclonal antibody drug’ emergency-use since last November to treat recently diagnosed Covid-19, but the updated authorization comes as it was confirmed that it reduces the risk of hospitalization or death by 70% in in high-risk non-hospitalized patients with mild to moderate symptoms.

According to Regeneron, that the antibody cocktail has also demonstrated efficacy against variants of the virus, including those first identified in Brazil and South Africa.

Regeneron has already received emergency authorization for treating adults with mild to moderate COVID-19 and pediatric patients aged 12 years and older who are at higher risk for progressing to severe COVID-19.

The company is also developing the cocktail as a preventive medicine after clinical studies reported positive data that showed it protected household contacts from exposure to the coronavirus and reduced the risk of progressing to symptomatic COVID-19.

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