FDA authorizes Regeneron's COVID-19 antibody drug for injections

FDA authorizes Regeneron's COVID-19 antibody drug for injections
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The Food and Drug Administration (FDA) has authorized Regeneron’s COVID-19 antibody drug for injections.

Regeneron said in a statement on Friday that the agency updated the emergency use authorization for REGEN-COV, lowering the dose from 2,400 mg to 1,200 mg.

The authorization also says the drug should be administered by intravenous infusion or subcutaneous injection when an infusion is not feasible.

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Regeneron said it plans to deliver at least 1 million doses to the federal government by the second quarter of this year. It expects to file for full approval of the drug in non-hospitalized outpatients later this summer.

The company 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 said in April that it is planning to ask the FDA to allow the drug to be used as a preventative treatment for COVID-19.

The updated authorization is based on data from several trials, including one which showed the antibody drug reduced the risk of hospitalization or death by 70 percent in high-risk non-hospitalized patients.

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

The FDA recently revoked emergency authorization from an antibody treatment from Eli Lilly because the variants resisted the therapy.

Another treatment, from GlaxoSmithKline and Vir Biotechnology, which the FDA authorized late last month, has shown efficacy against variants in lab studies.