The U.S. Food and Drug Administration (FDA) is now allowing the dosage of Regeneron”™s monoclonal antibody cocktail to treat Covid-19 to be cut in half, and the drug to be administered by subcutaneous injection as well as infusion.
The Tarrytown pharmaceutical company announced this morning that the FDA has updated the Emergency Use Authorization for the REGEN-COV cocktail of two monoclonal antibodies.
REGEN-COV was originally authorized to be given by infusion at a dosage of 2,400 milligrams (mg). The FDA”™s update cuts the authorized dosage in half and allows for the drug to be administered by injection under the skin in circumstances when infusions would delay treatment or not otherwise be practical to perform.
The FDA acted following Regeneron’s submitting new clinical trial data showing that the 1,200 mg dose was as effective as the 2,400 mg dose in reducing the risk of hospitalization or death from the Covid-19 SARS-CoV-2 virus.
George D. Yancopoulos, president and chief scientific officer at Regeneron, said: “Despite increased use of vaccines, thousands of patients are still becoming infected in the U.S. every day, with many at high risk of serious complications from Covid-19. Unfortunately, to date only a fraction of patients eligible for antibody treatments have received them, which we hope will change based on this updated FDA authorization.
“REGEN-COV is readily available and supplied free of charge by the U.S. government,” he noted.
The government and Regeneron have an arrangement under which the government will purchase up to 1.25 million doses of REGEN-COV through Sept. 30. The company said it expects to deliver at least a million doses to the government in the second quarter.
Regeneron this summer plans to submit a Biologics License Application to the FDA asking for full approval of REGEN-COV. The current Emergency Use Authorization allows its use to treat mild-to-moderate Covid-19 in adults and certain pediatric patients who have tested positive for the virus and are at high risk for the disease progressing to the point that hospitalization is required or death threatened.
Regeneron also reports that research shows that REGEN-COV is effective against the Brazilian and South African variants of the virus, which are increasingly appearing in the states of Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington.
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